Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: adalimumab	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

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) [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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) [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
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.

Enrollment:	309
Study Start Date:	August 2004
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Adalimumab 40 mg every other week (eow)	Biological: adalimumab 40 mg eow, sc Other Names: ABT-D2E7 Humira adalimumab

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235872

Locations

Japan

Tokyo, Metropolis, Japan

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

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Co., Ltd.

Investigators

Study Director:

Shigeki Hashimoto, Ph.D.

Abbott

More Information

No publications provided

Responsible Party:	Eiichi Makino, Abbott
ClinicalTrials.gov Identifier:	NCT00235872 History of Changes
Other Study ID Numbers:	M03-651
Study First Received:	October 7, 2005
Results First Received:	December 9, 2009
Last Updated:	April 7, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Rheumatoid arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013