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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 3

Contacts and Locations

Study 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

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:

• 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

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; 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: 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 of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)	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.	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 ACR Criteria, by Visit	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	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 ACR Criteria by Visit	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	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'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	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	Every 4 weeks 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 (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit	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	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 (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit	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	Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit	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	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 ACR Criteria by Visit	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	Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Presence of Morning Stiffness by Visit	The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).	Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Duration (Minutes) of the Presence of Morning Stiffness by Visit	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.	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, PhD, Abbott Japan

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: January 10, 2008
• First Submitted That Met QC Criteria: January 28, 2008
• First Posted (Estimate): January 29, 2008

Study Record Updates

• Last Update Posted (Estimate): June 21, 2011
• Last Update Submitted That Met QC Criteria: June 17, 2011
• Last Verified: June 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: M05-775