Clinical trial NCT00235833: Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Official title: Long-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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: 25
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, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Participation in the prior adalimumab study
* Body weight less than 100 kg.
* Subject's who wished to continue the study drug administration
* 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.

Exclusion Criteria:

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

  * Advanced or poorly controlled diabetes
  * Any poorly controlled medical condition
  * Intra-articular, intramuscular or iv administration of corticosteroids
  * Joint surgery.
* A subject who has been prescribed excluded medications during previous adalimumab study.
* History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
* A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
* Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.

Primary outcomes:
measure: Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
timeFrame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to 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 6 weeks up to Week 24 and every 12 weeks thereafter up to 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 6 weeks up to Week 24 and every 12 weeks thereafter up to 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 Possible Assessment), a Component of the ACR Criteria, by Visit
timeFrame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to 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 Possible Assessment), a Component of the ACR Criteria, by Visit
timeFrame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
measure: Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
timeFrame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
measure: Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
timeFrame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
measure: Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
timeFrame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
measure: Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
timeFrame: Every 6 weeks up to Week 24 and every 12 weeks thereafter
measure: Number of Subjects With Morning Stiffness at Each Visit
timeFrame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Other outcomes:
Locations:
city: Tokyo
country: Japan
state: Metropolis
city: Fukuoka
country: Japan
state: Prefecture
city: Hiroshima
country: Japan
state: Prefecture
city: Ibaraki
country: Japan
state: Prefecture
city: Nagasaki
country: Japan
state: Prefecture
city: Osaka
country: Japan
state: Prefecture
city: Saitama
country: Japan
state: Prefecture
Study officials:
affiliation: Abbott
name: Shigeki Hashimoto, Ph.D.
role: STUDY_DIRECTOR
References: