Back to resultsSelf-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adalimumab
Arm Description
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
Outcomes
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)
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
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
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT00603993
First Posted
January 10, 2008
Last Updated
June 17, 2011
Sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd, Eisai Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00603993
Brief Title
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Official Title
A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd, Eisai Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira, ABT-D2E7
Intervention Description
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
Primary Outcome Measure Information:
Title
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Description
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.
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Description
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
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Title
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Description
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
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Title
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
Description
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
Time Frame
Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Title
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
Description
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
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Title
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
Description
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
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Title
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Description
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
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Title
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Description
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
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Title
Presence of Morning Stiffness by Visit
Description
The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Title
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Description
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.
Time Frame
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeki Hashimoto, PhD
Organizational Affiliation
Abbott Japan
Official's Role
Study Director
Facility Information:
City
Aichi
Country
Japan
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Gunma
Country
Japan
City
Hokkaido
Country
Japan
City
Hyogo
Country
Japan
City
Ibaraki
Country
Japan
City
Kanagawa
Country
Japan
City
Miyagi
Country
Japan
City
Nagano
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Saitama
Country
Japan
City
Shizuoka
Country
Japan
City
Tokyo
Country
Japan
City
Toyama
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
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