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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Double-blind adalimumab

Double-blind Placebo

Open-label Adalimumab

Open-labelAdalimumabRescue

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Rheumatoid arthritis based on the American College of Rheumatology criteria
Methotrexate or leflunomide naïve
Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
Joint surgery involving joints to be assessed within 8 weeks prior to Screening

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Arm Label

DB Placebo

DB adalimumab

DB Adalimumab/OL Adalimumab

DB Placebo/OL Adalimumab

DB Adalimumab/RE OL Adalimumab

DB Placebo/RE OL Adalimumab

Arm Description

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Outcomes

Primary Outcome Measures

Change From Baseline in Modified Total Sharp X-Ray Score at Week 26

Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.

Secondary Outcome Measures

Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)

Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.

Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)

Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.

Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)

Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.

Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26

Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.

Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26

Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26

Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.

Change From Baseline in Modified Total Sharp X-Ray Score at Week 52

Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.

Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.

Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.

Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.

Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52

Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52

Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52

Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.

Full Information

NCT ID

NCT00870467

First Posted

March 26, 2009

Last Updated

August 1, 2012

Sponsor

Abbott

Collaborators

Eisai Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00870467

Brief Title

A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

Official Title

A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

Collaborators

Eisai Co., Ltd.

4. Oversight

5. Study Description

Brief Summary

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

Detailed Description

This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug [adalimumab or placebo] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

334 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DB Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

DB adalimumab

Arm Type

Experimental

Arm Description

Arm Title

DB Adalimumab/OL Adalimumab

Arm Type

Experimental

Arm Description

Arm Title

DB Placebo/OL Adalimumab

Arm Type

Experimental

Arm Description

Arm Title

DB Adalimumab/RE OL Adalimumab

Arm Type

Experimental

Arm Description

Arm Title

DB Placebo/RE OL Adalimumab

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Double-blind adalimumab

Other Intervention Name(s)

ABT-D2E7, adalimumab, Humira

Intervention Description

Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)

Intervention Type

Drug

Intervention Name(s)

Double-blind Placebo

Other Intervention Name(s)

Placebo

Intervention Description

Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)

Intervention Type

Biological

Intervention Name(s)

Open-label Adalimumab

Other Intervention Name(s)

ABT-D2E7, adalimumab, Humira

Intervention Description

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

Intervention Type

Biological

Intervention Name(s)

Open-labelAdalimumabRescue

Other Intervention Name(s)

ABT-D2E7, adalimumab, Humira

Intervention Description

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26

Primary Outcome Measure Information:

Title

Change From Baseline in Modified Total Sharp X-Ray Score at Week 26

Description

Time Frame

Baseline, Week 26

Secondary Outcome Measure Information:

Title

Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)

Description

Time Frame

Week 26

Title

Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)

Description

Time Frame

Week 26

Title

Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)

Description

Time Frame

Week 26

Title

Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26

Description

Time Frame

Baseline, Week 26

Title

Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26

Description

Time Frame

Week 26

Title

Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26

Description

Time Frame

Through Week 26

Title

Change From Baseline in Modified Total Sharp X-Ray Score at Week 52

Description

Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.

Time Frame

Baseline, Week 52

Title

Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Description

Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.

Time Frame

Week 52

Title

Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Description

Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.

Time Frame

Week 52

Title

Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Description

Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.

Time Frame

Week 52

Title

Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52

Description

Time Frame

Baseline, Week 52

Title

Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52

Description

Time Frame

Week 52

Title

Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52

Description

Time Frame

Through Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Rheumatoid arthritis based on the American College of Rheumatology criteria Methotrexate or leflunomide naïve Disease duration less than or equal to 2 years from diagnosis Exclusion Criteria History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus Joint surgery involving joints to be assessed within 8 weeks prior to Screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroshi Ukai, BS

Organizational Affiliation

Abbott Japan Co.,Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 46861

City

Anjo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46919

City

Aomori

Country

Japan

Facility Name

Site Reference ID/Investigator# 46805

City

Chiba

Country

Japan

Facility Name

Site Reference ID/Investigator# 46806

City

Chiba

Country

Japan

Facility Name

Site Reference ID/Investigator# 46880

City

Chiba

Country

Japan

Facility Name

Site Reference ID/Investigator# 46881

City

Chiba

Country

Japan

Facility Name

Site Reference ID/Investigator# 46890

City

Fuchu

Country

Japan

Facility Name

Site Reference ID/Investigator# 46902

City

Fukuoka

Country

Japan

Facility Name

Site Reference ID/Investigator# 46903

City

Fukuoka

Country

Japan

Facility Name

Site Reference ID/Investigator# 46904

City

Fukuoka

Country

Japan

Facility Name

Site Reference ID/Investigator# 46856

City

Gifu

Country

Japan

Facility Name

Site Reference ID/Investigator# 46944

City

Gunma

Country

Japan

Facility Name

Site Reference ID/Investigator# 46893

City

Hiroshima

Country

Japan

Facility Name

Site Reference ID/Investigator# 46894

City

Hiroshima

Country

Japan

Facility Name

Site Reference ID/Investigator# 12161

City

Hokkaido

Country

Japan

Facility Name

Site Reference ID/Investigator# 46916

City

Hokkaido

Country

Japan

Facility Name

Site Reference ID/Investigator# 46918

City

Hokkaido

Country

Japan

Facility Name

Site Reference ID/Investigator# 46865

City

Hyogo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46871

City

Hyogo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46801

City

Ibaraki

Country

Japan

Facility Name

Site Reference ID/Investigator# 46925

City

Ibaraki

Country

Japan

Facility Name

Site Reference ID/Investigator# 46800

City

Iwate

Country

Japan

Facility Name

Site Reference ID/Investigator# 46873

City

Kagoshima

Country

Japan

Facility Name

Site Reference ID/Investigator# 46874

City

Kagoshima

Country

Japan

Facility Name

Site Reference ID/Investigator# 46845

City

Kanagawa

Country

Japan

Facility Name

Site Reference ID/Investigator# 46899

City

Kanagawa

Country

Japan

Facility Name

Site Reference ID/Investigator# 46901

City

Kanagawa

Country

Japan

Facility Name

Site Reference ID/Investigator# 46851

City

Kanazawa

Country

Japan

Facility Name

Site Reference ID/Investigator# 46852

City

Kanazawa

Country

Japan

Facility Name

Site Reference ID/Investigator# 46802

City

Kawagoe

Country

Japan

Facility Name

Site Reference ID/Investigator# 46900

City

Kawasaki

Country

Japan

Facility Name

Site Reference ID/Investigator# 46875

City

Kirishima

Country

Japan

Facility Name

Site Reference ID/Investigator# 46870

City

Kitakyushu

Country

Japan

Facility Name

Site Reference ID/Investigator# 46872

City

Kumamoto

Country

Japan

Facility Name

Site Reference ID/Investigator# 46912

City

Kumamoto

Country

Japan

Facility Name

Site Reference ID/Investigator# 46864

City

Kyoto

Country

Japan

Facility Name

Site Reference ID/Investigator# 46943

City

Maebashi

Country

Japan

Facility Name

Site Reference ID/Investigator# 46898

City

Matsuyama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46915

City

Miyazaki

Country

Japan

Facility Name

Site Reference ID/Investigator# 46853

City

Nagano

Country

Japan

Facility Name

Site Reference ID/Investigator# 46855

City

Nagano

Country

Japan

Facility Name

Site Reference ID/Investigator# 46909

City

Nagasaki

Country

Japan

Facility Name

Site Reference ID/Investigator# 46910

City

Nagasaki

Country

Japan

Facility Name

Site Reference ID/Investigator# 46911

City

Nagasaki

Country

Japan

Facility Name

Site Reference ID/Investigator# 46858

City

Nagoya

Country

Japan

Facility Name

Site Reference ID/Investigator# 46860

City

Nagoya

Country

Japan

Facility Name

Site Reference ID/Investigator# 46877

City

Nara

Country

Japan

Facility Name

Site Reference ID/Investigator# 46885

City

Nara

Country

Japan

Facility Name

Site Reference ID/Investigator# 46848

City

Niigata

Country

Japan

Facility Name

Site Reference ID/Investigator# 46906

City

Niigata

Country

Japan

Facility Name

Site Reference ID/Investigator# 46914

City

Oita

Country

Japan

Facility Name

Site Reference ID/Investigator# 46869

City

Okayama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46886

City

Okayama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46887

City

Okayama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46892

City

Okayama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46876

City

Okinawa

Country

Japan

Facility Name

Site Reference ID/Investigator# 46946

City

Osaka

Country

Japan

Facility Name

Site Reference ID/Investigator# 46947

City

Osaka

Country

Japan

Facility Name

Site Reference ID/Investigator# 46842

City

Rifu

Country

Japan

Facility Name

Site Reference ID/Investigator# 46846

City

Sagamihara

Country

Japan

Facility Name

Site Reference ID/Investigator# 46803

City

Saitama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46804

City

Saitama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46878

City

Saitama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46879

City

Saitama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46917

City

Sapporo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46942

City

Shimotsuke

Country

Japan

Facility Name

Site Reference ID/Investigator# 46854

City

Shizuoka

Country

Japan

Facility Name

Site Reference ID/Investigator# 46857

City

Shizuoka

Country

Japan

Facility Name

Site Reference ID/Investigator# 46859

City

Shizuoka

Country

Japan

Facility Name

Site Reference ID/Investigator# 46895

City

Takamatsu

Country

Japan

Facility Name

Site Reference ID/Investigator# 46843

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46844

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46850

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46882

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46883

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46884

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46888

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46889

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46891

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46896

City

Tokyo

Country

Japan

Facility Name

Site Reference ID/Investigator# 46849

City

Toyama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46907

City

Toyama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46862

City

Toyoake

Country

Japan

Facility Name

Site Reference ID/Investigator# 46866

City

Toyohashi

Country

Japan

Facility Name

Site Reference ID/Investigator# 46926

City

Tsukuba

Country

Japan

Facility Name

Site Reference ID/Investigator# 46863

City

Tsu

Country

Japan

Facility Name

Site Reference ID/Investigator# 46897

City

Yokohama

Country

Japan

Facility Name

Site Reference ID/Investigator# 46905

City

Yokohama

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

27338778

Citation

Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

Results Reference

derived

PubMed Identifier

24441150

Citation

Yamanaka H, Ishiguro N, Takeuchi T, Miyasaka N, Mukai M, Matsubara T, Uchida S, Akama H, Kupper H, Arora V, Tanaka Y. Recovery of clinical but not radiographic outcomes by the delayed addition of adalimumab to methotrexate-treated Japanese patients with early rheumatoid arthritis: 52-week results of the HOPEFUL-1 trial. Rheumatology (Oxford). 2014 May;53(5):904-13. doi: 10.1093/rheumatology/ket465. Epub 2014 Jan 17.

Results Reference

derived

Learn more about this trial

A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial