Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: adalimumab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Long-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
Number of subjects with American College of Rheumatology (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 functional disability via a health assessment questionnaire [HAQ], 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 [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (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 [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria
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 [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), 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 Possible Assessment), a Component of the ACR Criteria, by Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's 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 (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 [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire [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 the of ACR criteria, by visit
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein [CRP; mg/dL], a component of the ACR criteria, by visit.
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) [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter ] [ Designated as safety issue: No ]
Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts [TJC or SJC, respectively] and 20% improvement in 3 of the following 5 criteria: [1] Physician's global assessment (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein (CRP)
Number of Subjects With Morning Stiffness at Each Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ] [ Designated as safety issue: No ]
The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).

Enrollment:	25
Study Start Date:	June 2003
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Adalimumab 40 mg eow	Biological: adalimumab 40 mg every other week (eow), subcutaneous (sc) Other Names: ABT-D2E7 Humira adalimumab

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235833

Locations

Japan

Tokyo, Metropolis, Japan

Fukuoka, Prefecture, Japan

Hiroshima, Prefecture, Japan

Ibaraki, Prefecture, Japan

Nagasaki, Prefecture, Japan

Osaka, Prefecture, Japan

Saitama, Prefecture, Japan

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Co., Ltd.

Investigators

Study Director:

Shigeki Hashimoto, Ph.D.

Abbott

More Information

No publications provided

Responsible Party:	Eiichi Makino, Abbott
ClinicalTrials.gov Identifier:	NCT00235833 History of Changes
Other Study ID Numbers:	M02-564
Study First Received:	October 7, 2005
Results First Received:	October 12, 2009
Last Updated:	April 7, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Rheumatoid Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013