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

• ClinicalTrials.gov Identifier: NCT00603993
• Recruitment Status: Completed
• First Posted: January 29, 2008
• Results First Posted: February 4, 2010
• Last Update Posted: June 21, 2011
• Sponsor: Abbott
• Collaborators: Abbott Japan Co.,Ltd; Eisai Co., Ltd.
• Information provided by: Abbott

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Biological: Adalimumab	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: March 2006
• Actual Primary Completion Date: November 2006

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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) ]
   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 :

1. 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) ]
   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
2. 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) ]
   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
3. 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) ]
   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
4. 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) ]
   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
5. 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) ]
   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
6. 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) ]
   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
7. 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) ]
   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
8. 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) ]
   The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
9. 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) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Eiichi Makino, Abbott
• ClinicalTrials.gov Identifier: NCT00603993
• Other Study ID Numbers: M05-775
• First Posted: January 29, 2008
• Results First Posted: February 4, 2010
• Last Update Posted: June 21, 2011
• Last Verified: June 2011

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; Antirheumatic Agents