46. Malignant rheumatoid arthritis
4,183 clinical trials,   2,538 drugs   (DrugBank: 401 drugs),   183 drug target genes,   219 drug target pathways

Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
20 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004834-11-GB
(EUCTR)
23/10/201716/08/2017A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritisA randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis - CR6086-2-02 Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR0686
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR6086
Trade Name: Methotrexate ® 2.5mg Tablets
Product Name: Methotrexate ® 2.5mg Tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets
Rottapharm Biotech S.r.l.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
2EUCTR2015-003376-75-BG
(EUCTR)
02/08/201618/07/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
3EUCTR2015-003376-75-CZ
(EUCTR)
27/07/201603/06/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
4EUCTR2015-003334-27-CZ
(EUCTR)
27/07/201606/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
5EUCTR2015-003376-75-HU
(EUCTR)
06/07/201609/06/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-003376-75-PL
(EUCTR)
28/06/201608/06/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Belgium;Poland;Australia;Bulgaria;Japan;New Zealand
7EUCTR2015-003334-27-PL
(EUCTR)
28/06/201608/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
8EUCTR2015-003334-27-LV
(EUCTR)
17/06/201608/06/2016A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL 2,5mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;European Union;Mexico;Canada;Argentina;Brazil;Kazakhstan;New Zealand;Japan;United States
9EUCTR2015-003334-27-IE
(EUCTR)
17/06/201607/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
10EUCTR2015-003334-27-PT
(EUCTR)
17/06/201609/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3United States;Belarus;Portugal;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-003376-75-PT
(EUCTR)
17/06/201609/06/2016A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
12EUCTR2015-003334-27-GB
(EUCTR)
15/06/201609/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
13EUCTR2015-003376-75-AT
(EUCTR)
10/06/201628/06/2016A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
14EUCTR2015-003334-27-BE
(EUCTR)
07/06/201606/06/2016A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
975Phase 3South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand;Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia
15EUCTR2015-003376-75-BE
(EUCTR)
07/06/201606/06/2016A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-002324-32-SE
(EUCTR)
27/03/201320/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
17EUCTR2012-002324-32-BE
(EUCTR)
25/02/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
18EUCTR2012-002324-32-DE
(EUCTR)
23/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
19EUCTR2012-002324-32-PT
(EUCTR)
18/01/201302/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
20EUCTR2012-002324-32-AT
(EUCTR)
14/01/201309/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden