Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: adalimumab

• Study Type: Interventional
• Enrollment (Actual): 309
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Metropolis
    • Tokyo, Metropolis, Japan
  • Prefecture
    • Aichi, Prefecture, Japan
    • Chiba, Prefecture, Japan
    • Ehime, Prefecture, Japan
    • Fukui, Prefecture, Japan
    • Fukuoka, Prefecture, Japan
    • Gunma, Prefecture, Japan
    • Hokkaido, Prefecture, Japan
    • Hyogo, Prefecture, Japan
    • Ibaraki, Prefecture, Japan
    • Ishikawa, Prefecture, Japan
    • Kagoshima, Prefecture, Japan
    • Kanagawa, Prefecture, Japan
    • Kyoto, Prefecture, Japan
    • Miyagi, Prefecture, Japan
    • Nagano, Prefecture, Japan
    • Nagasaki, Prefecture, Japan
    • Niigata, Prefecture, Japan
    • Okayama, Prefecture, Japan
    • Osaka, Prefecture, Japan
    • Saitama, Prefecture, Japan
    • Shizuoka, Prefecture, Japan
    • Tochigi, Prefecture, Japan
    • Tokushima, Prefecture, Japan
    • Toyama, Prefecture, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adalimumab 40 mg every other week (eow)	Biological: adalimumab; 40 mg eow, sc; Other Names: ABT-D2E7; Humira

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Eisai Co., Ltd.; Abbott Japan Co.,Ltd
• Investigators: Study Director: Shigeki Hashimoto, Ph.D., Abbott

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: October 7, 2005
• First Submitted That Met QC Criteria: October 11, 2005
• First Posted (Estimate): October 12, 2005

Study Record Updates

• Last Update Posted (Estimate): April 11, 2011
• Last Update Submitted That Met QC Criteria: April 7, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: M03-651