Clinical trial NCT00603993: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Abbott Japan Co.,Ltd
name: Eisai Co., Ltd.
First posted: 2008-01-29
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Secondary outcomes:
measure: Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
measure: Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
measure: 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
timeFrame: Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
measure: 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
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
measure: 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
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
measure: Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
measure: Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
measure: Presence of Morning Stiffness by Visit
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
measure: Duration (Minutes) of the Presence of Morning Stiffness by Visit
timeFrame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Other outcomes:
Locations:
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
Study officials:
affiliation: Abbott Japan
name: Shigeki Hashimoto, PhD
role: STUDY_DIRECTOR
References: