Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborators:
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00603993
First received: January 10, 2008
Last updated: June 17, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.


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: A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 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, ACR50, and ACR70, 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 physical disability via a health assessment questionnaire disability index(HAQ-DI), 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 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 (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit

  • Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), 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 ]
    Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit

  • Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit [ Time Frame: Every 4 weeks 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 (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit

  • Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), 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 ]
    mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit

  • Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), 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 ]
    Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit

  • Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), 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 ]
    Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 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

  • Mean Change From Baseline in C-reactive Protein (CRP), 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 ]
    Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit

  • Presence 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 ]
    The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).

  • Duration (Minutes) of the Presence 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 from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.


Enrollment: 88
Study Start Date: March 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT 00235872]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
Biological: Adalimumab
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
Other Names:
  • Humira
  • ABT-D2E7
  • adalimumab

  Eligibility

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

Inclusion Criteria:

  • Completed Week 36 of Study M03-651 [NCT 00235872]
  • Wish to participate in self-injection study
  • Give written informed consent
  • Comply with protocol requirements

Exclusion Criteria:

  • Subject develops serious adverse events at time of eligibility confirmation
  • Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
  • Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
  • The investigator considers the subject inappropriate for participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603993

Locations
Japan
Aichi, Japan
Chiba, Japan
Fukuoka, Japan
Gunma, Japan
Hokkaido, Japan
Hyogo, Japan
Ibaraki, Japan
Kanagawa, Japan
Miyagi, Japan
Nagano, Japan
Okayama, Japan
Osaka, Japan
Saitama, Japan
Shizuoka, Japan
Tokyo, Japan
Toyama, Japan
Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Investigators
Study Director: Shigeki Hashimoto, PhD Abbott Japan
  More Information

No publications provided

Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00603993     History of Changes
Other Study ID Numbers: M05-775
Study First Received: January 10, 2008
Results First Received: October 16, 2009
Last Updated: June 17, 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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 01, 2014