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

Sponsor:	Abbott
Collaborators:	Abbott Japan Co.,Ltd Eisai Limited
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00235833

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 II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled 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 ]

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 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 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 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 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 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 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 ]
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 ]
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 ]

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

Arms	Assigned Interventions
Adalimumab 40 mg eow: Experimental	Biological: adalimumab 40 mg every other week (eow), subcutaneous (sc)

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, Metropolis

Tokyo, Metropolis, Japan
Japan, Prefecture

Fukuoka, Prefecture, Japan

Hiroshima, Prefecture, Japan

Saitama, Prefecture, Japan

Nagasaki, Prefecture, Japan

Osaka, Prefecture, Japan

Ibaraki, Prefecture, Japan

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Limited

Investigators

Study Director:

Shigeki Hashimoto, Ph.D.

Abbott

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M02-564
Study First Received:	October 7, 2005
Results First Received:	October 12, 2009
Last Updated:	January 5, 2010
ClinicalTrials.gov Identifier:	NCT00235833 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Rheumatoid Arthritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on March 18, 2010