DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
46	悪性関節リウマチ	3
53	シェーグレン症候群	1
70	広範脊柱管狭窄症	1
97	潰瘍性大腸炎	0
226	間質性膀胱炎（ハンナ型）	2
231	α1-アンチトリプシン欠乏症	1
299	嚢胞性線維症	0

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	JPRN-jRCTs041200048	02/10/2020	02/10/2020	Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state	Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study	Rheumatoid arthritis	1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. Folic acid is continued if concomitantly used. - Withdrawn group: Week 0 to 12 Reduced after registration. The dose of MTX is reduced to half, regardless of the initial dose. Folic acid is continued if concomitantly used. Week 12 to 52 Discontinued if low disease activity was maintained. Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) CZP and csDMARDs other than MTX Continued at a stable dose and interval throughout the course of the study in both groups. 3) Glucocorticoids Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group. 4) Rescue treatment One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request. - Restoring, restarting, or increasing doses of MTX - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Kojima Toshihisa	NULL	Recruiting	>= 20age old	Not applicable	Both	114	N/A	Japan
2	JPRN-jRCT1041190125	09/03/2020	09/03/2020	PRECIOUS-B study	Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study	Rheumatoid arthritis	1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose. - The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used. Week 12 to 52 - Discontinued if low disease activity was maintained. - Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) BAR - Continued at a stable dose and interval throughout the course of the study. 3) csDMARDs other than MTX - Continued at a stable dose and interval throughout the course of the study. 4) Glucocorticoids - Continued at a stable dose up to week 36, and allowed to taper after week 36. 5) Rescue treatments One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request - Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX. - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids. - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Takahashi Nobunori	NULL	Pending	>= 20age old	Not applicable	Both	51	N/A	Japan
3	JPRN-jRCTs041180071	13/10/2016	07/03/2019	T-ReX study	Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study	Rheumatoid arthritis	At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Kojima Toshihisa	NULL	Complete	>= 20age old	Not applicable	Both	51	N/A	Japan

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

JPRN-jRCTs041200048

02/10/2020

Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state

Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study

Rheumatoid arthritis

1) MTX*
- Continued group:
Continued at a stable dose and interval throughout the cours of the study.
Folic acid is continued if concomitantly used.
- Withdrawn group:
Week 0 to 12
Reduced after registration.
The dose of MTX is reduced to half, regardless of the initial dose.
Folic acid is continued if concomitantly used.
Week 12 to 52
Discontinued if low disease activity was maintained.
Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) CZP and csDMARDs other than MTX
Continued at a stable dose and interval throughout the course of the study in both groups.

3) Glucocorticoids
Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group.

4) Rescue treatment
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request.
- Restoring, restarting, or increasing doses of MTX
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.

Kojima Toshihisa

NULL

Recruiting

>= 20age old

Not applicable

Both

114

N/A

Japan

JPRN-jRCT1041190125

09/03/2020

PRECIOUS-B study

Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study

Rheumatoid arthritis

1) MTX*
Week 0 to 12
- Reduced after registration.
- The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose.
- The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used.
Week 12 to 52
- Discontinued if low disease activity was maintained.
- Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) BAR
- Continued at a stable dose and interval throughout the course of the study.

3) csDMARDs other than MTX
- Continued at a stable dose and interval throughout the course of the study.

4) Glucocorticoids
- Continued at a stable dose up to week 36, and allowed to taper after week 36.

5) Rescue treatments
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request
- Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX.
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids.
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.

Takahashi Nobunori

NULL

Pending

>= 20age old

Not applicable

Both

N/A

Japan

JPRN-jRCTs041180071

13/10/2016

07/03/2019

T-ReX study

Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study

Rheumatoid arthritis

At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.

Kojima Toshihisa

NULL

Complete

>= 20age old

Not applicable

Both

N/A

Japan

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	NCT02257957 (ClinicalTrials.gov)	November 2014	24/9/2014	Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye	Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye	Dry Eye;Sjogren Syndrome	Drug: PRP injection;Drug: Standard care Hyaluronic acid eye drops	Universidad Nacional de Colombia	NULL	Not yet recruiting	18 Years	N/A	Both	30	Phase 3	NULL

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	NCT02459392 (ClinicalTrials.gov)	December 2020	26/5/2015	EuroPainClinics® Study II (Prospective Trial)	EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial)	Lumbar Spinal Stenosis	Other: Epiduroscopy;Drug: Hyaluronic Acid;Drug: DepoMedrol	Europainclinics z.ú.	NULL	Recruiting	18 Years	N/A	All	300	N/A	Czechia;Czech Republic

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	NCT03463499 (ClinicalTrials.gov)	September 22, 2017	25/2/2018	The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients	The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients	Interstitial Cystitis	Drug: Hyaluronic Acid and Chondroitin Sulfate	Samsung Medical Center	NULL	Active, not recruiting	20 Years	N/A	All	62	N/A	Korea, Republic of
2	NCT01813565 (ClinicalTrials.gov)	March 20, 2013	11/3/2013	The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.	The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.	Interstitial Cystitis	Drug: Hyaluronic acid/chondroitin sulfate	Asan Medical Center	NULL	Terminated	20 Years	N/A	All	15	N/A	Korea, Republic of

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

NCT03463499
(ClinicalTrials.gov)

September 22, 2017

25/2/2018

The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

Interstitial Cystitis

Drug: Hyaluronic Acid and Chondroitin Sulfate

Samsung Medical Center

NULL

Active, not recruiting

20 Years

N/A

All

N/A

Korea, Republic of

NCT01813565
(ClinicalTrials.gov)

March 20, 2013

11/3/2013

The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.

Interstitial Cystitis

Drug: Hyaluronic acid/chondroitin sulfate

Asan Medical Center

NULL

Terminated

20 Years

N/A

All

N/A

Korea, Republic of