DDrare: Database of Drug Development for Rare Diseases

ID	Disease name (Link within this page)	Number of trials
46	Malignant rheumatoid arthritis	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2011-002024-40-ES (EUCTR)	16/02/2012	14/10/2011	Proof-of-Concept Study with BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 14.0;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: CCR1 Antagonist Product Code: BMS-817399	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	172		Russian Federation;Mexico;Argentina;Korea, Republic of;Spain;United States;South Africa
2	NCT01404585 (ClinicalTrials.gov)	September 2011	27/7/2011	Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: Placebo;Drug: BMS-817399	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	Both	123	Phase 2	United States;Argentina;Korea, Republic of;Mexico;Russian Federation;South Africa;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-002024-40-ES
(EUCTR)

16/02/2012

14/10/2011

Proof-of-Concept Study with BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis
MedDRA version: 14.0;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: CCR1 Antagonist
Product Code: BMS-817399

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

172

Russian Federation;Mexico;Argentina;Korea, Republic of;Spain;United States;South Africa

NCT01404585
(ClinicalTrials.gov)

September 2011

27/7/2011

Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: BMS-817399

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

123

Phase 2

United States;Argentina;Korea, Republic of;Mexico;Russian Federation;South Africa;Spain