Skip to main content
OpenTrials
Completed

NCT Number: NCT00235872

Adalimumab in Adult Japanese 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo, Metropolis, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Biological

40 mg eow, sc

Other names: ABT-D2E7, Humira

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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).

    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.

  4. 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).

    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.

  5. 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).

    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.

  6. 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)

    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

  7. 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)

    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.

  8. 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)

    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.

  9. 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)

    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.

  10. 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)

    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.

  11. 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)

    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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
First posted
Oct 12, 2005
Registry last updated
Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.