Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

adalimumab

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: Participation and completion until Week 24 of the prior adalimumab dose-ranging study. Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion. Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy. Exclusion Criteria: A subject who experienced any of the following during prior study: Advanced or poorly controlled diabetes Joint surgery (joint evaluated in this study) A subject who has been prescribed excluded medications during prior study. History of following during prior study: Clinically significant drug or alcohol abuse Intravenous (iv) drug abuse Active infection with listeria or tuberculosis (TB) Lymphoma, leukemia And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin. A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab 40 mg every other week (eow)

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)

Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.

Secondary Outcome Measures

Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit

Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit

Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.

Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit

Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.

Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit

Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.

Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit

Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.

Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit

Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions

Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit

Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Presence of Morning Stiffness

The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit

Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Presence of Rheumatoid Factor (RF)

The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.

Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit

Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Full Information

NCT ID

NCT00235872

First Posted

October 7, 2005

Last Updated

April 7, 2011

Sponsor

Abbott

Collaborators

Abbott Japan Co.,Ltd, Eisai Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00235872

Brief Title

Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Official Title

Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

July 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

Collaborators

Abbott Japan Co.,Ltd, Eisai Co., Ltd.

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

309 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab 40 mg every other week (eow)

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

40 mg eow, sc

Primary Outcome Measure Information:

Title

Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)

Description

Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit

Description

Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

Title

Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit

Description

Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

Title

Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit

Description

Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).

Title

Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit

Description

Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).

Title

Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit

Description

Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).

Title

Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit

Description

Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

Title

Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit

Description

Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

Title

Presence of Morning Stiffness

Description

The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

Title

Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit

Description

Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

Title

Presence of Rheumatoid Factor (RF)

Description

The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

Title

Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit

Description

Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.

Time Frame

Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Participation and completion until Week 24 of the prior adalimumab dose-ranging study. Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion. Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy. Exclusion Criteria: A subject who experienced any of the following during prior study: Advanced or poorly controlled diabetes Joint surgery (joint evaluated in this study) A subject who has been prescribed excluded medications during prior study. History of following during prior study: Clinically significant drug or alcohol abuse Intravenous (iv) drug abuse Active infection with listeria or tuberculosis (TB) Lymphoma, leukemia And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin. A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shigeki Hashimoto, Ph.D.

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

City

Tokyo

State/Province

Metropolis

Country

Japan

City

Aichi

State/Province

Prefecture

Country

Japan

City

Chiba

State/Province

Prefecture

Country

Japan

City

Ehime

State/Province

Prefecture

Country

Japan

City

Fukui

State/Province

Prefecture

Country

Japan

City

Fukuoka

State/Province

Prefecture

Country

Japan

City

Gunma

State/Province

Prefecture

Country

Japan

City

Hokkaido

State/Province

Prefecture

Country

Japan

City

Hyogo

State/Province

Prefecture

Country

Japan

City

Ibaraki

State/Province

Prefecture

Country

Japan

City

Ishikawa

State/Province

Prefecture

Country

Japan

City

Kagoshima

State/Province

Prefecture

Country

Japan

City

Kanagawa

State/Province

Prefecture

Country

Japan

City

Kyoto

State/Province

Prefecture

Country

Japan

City

Miyagi

State/Province

Prefecture

Country

Japan

City

Nagano

State/Province

Prefecture

Country

Japan

City

Nagasaki

State/Province

Prefecture

Country

Japan

City

Niigata

State/Province

Prefecture

Country

Japan

City

Okayama

State/Province

Prefecture

Country

Japan

City

Osaka

State/Province

Prefecture

Country

Japan

City

Saitama

State/Province

Prefecture

Country

Japan

City

Shizuoka

State/Province

Prefecture

Country

Japan

City

Tochigi

State/Province

Prefecture

Country

Japan

City

Tokushima

State/Province

Prefecture

Country

Japan

City

Toyama

State/Province

Prefecture

Country

Japan

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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