Clinical trial NCT00235872: Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Official title: Open-Label Continuous Administration Study With Adalimumab (D2E7) in 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: 2005-10-12
Enrollment: 309
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 the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Participation and completion until Week 24 of the prior adalimumab dose-ranging study.
* Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
* Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.

Exclusion Criteria:

* A subject who experienced any of the following during prior study:

  * Advanced or poorly controlled diabetes
  * Joint surgery (joint evaluated in this study)
* A subject who has been prescribed excluded medications during prior study.
* History of following during prior study:

  * Clinically significant drug or alcohol abuse
  * Intravenous (iv) drug abuse
  * Active infection with listeria or tuberculosis (TB)
  * Lymphoma, leukemia
  * And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
* A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period

Primary outcomes:
measure: Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 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 American College of Rheumatology (ACR) 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 American College of Rheumatology (ACR) 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 Global Assessment of Disease Activity (PGA), 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 Global Assessment of Disease Activity Using a Visual Analog Scale, 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, 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 the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (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 American College of Rheumatology (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
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 the Duration (Minutes) 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: Presence of Rheumatoid Factor (RF)
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 Rheumatoid Factor (IU/ML) 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: Tokyo
country: Japan
state: Metropolis
city: Aichi
country: Japan
state: Prefecture
city: Chiba
country: Japan
state: Prefecture
city: Ehime
country: Japan
state: Prefecture
city: Fukui
country: Japan
state: Prefecture
city: Fukuoka
country: Japan
state: Prefecture
city: Gunma
country: Japan
state: Prefecture
city: Hokkaido
country: Japan
state: Prefecture
city: Hyogo
country: Japan
state: Prefecture
city: Ibaraki
country: Japan
state: Prefecture
city: Ishikawa
country: Japan
state: Prefecture
city: Kagoshima
country: Japan
state: Prefecture
city: Kanagawa
country: Japan
state: Prefecture
city: Kyoto
country: Japan
state: Prefecture
city: Miyagi
country: Japan
state: Prefecture
city: Nagano
country: Japan
state: Prefecture
city: Nagasaki
country: Japan
state: Prefecture
city: Niigata
country: Japan
state: Prefecture
city: Okayama
country: Japan
state: Prefecture
city: Osaka
country: Japan
state: Prefecture
city: Saitama
country: Japan
state: Prefecture
city: Shizuoka
country: Japan
state: Prefecture
city: Tochigi
country: Japan
state: Prefecture
city: Tokushima
country: Japan
state: Prefecture
city: Toyama
country: Japan
state: Prefecture
Study officials:
affiliation: Abbott
name: Shigeki Hashimoto, Ph.D.
role: STUDY_DIRECTOR
References: