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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603993
• Other study ID #: M05-775
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2008
• Last updated: June 17, 2011
• Start date: March 2006

Study information

• Verified date: June 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Adalimumab
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Abbott	Abbott Japan Co.,Ltd, Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No