A Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00538902

Purpose

The objective of this study is to determine the safety and efficacy profiles of two (SC) dose levels of adalimumab and placebo in adult Chinese subjects with active RA treated concomitantly with MTX

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: Placebo Biological: Adalimumab 40 mg Biological: Adalimumab 80 mg	Phase II Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Further study details as provided by Abbott:

Primary Outcome Measures:

ACR20 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Number (percentage) of responders [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ACR20 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
ACR70 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
TJC and SJC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:	302
Study Start Date:	September 2007
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Biological: Placebo Placebo SC eow for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks
Adalimumab 40 mg: Experimental	Biological: Adalimumab 40 mg Adalimumab 40 mg SC eow for 24 weeks
Adalimumab 80 mg: Experimental	Biological: Adalimumab 80 mg Adalimumab 80 mg SC eow for 12 weeks followed by adalimumab 40 mg SC eow for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet ACR criteria for diagnosis of active RA and have at both the Screening visit and Week 0 visit at least four swollen joints(out of 66 assessed)and at least six tender joints(out of 68 assessed)
Subjects must have failed prior treatment with one or more DMARDs
DMARDs (other than MTX) must be discontinued for = 28 days or at least 5 halflives, whichever is greater, before the Week 0 visit
Traditional Chinese Medicines must be discontinued for = 28 days before the Week 0 visit
Subjects must have received at least three months of treatment with MTX (minimum 7.5 mg/week) and remained on a stable dose of MTX for = 28 days prior to the Screening visit
Glucocorticoids equivalent to = 10 mg of prednisone and prednisone equivalent must remain unchanged for at least 28 days prior to the Week 0 visit
Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

A history of, or current, acute inflammatory joint disease of different origin (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years
Wheelchair-bound or bedridden
Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit
Intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the Screening visit
Prior treatment with any TNF antagonist, including adalimumab
Subject considered by the investigator, for any reason, to be an unsuitable candidate
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538902

Locations

China

Beijing, China, 100853

Beijing, China, 100730

Shanghai, China, 200433

Shanghai, China, 200001
China, Anhui Province

Hefei, Anhui Province, China, 230022
China, Beijing

Hepingjiebeikou, Beijing, China, 100029
China, Guangdong Province

Guangzhou, Guangdong Province, China, 510630

Guangzhou, Guangdong Province, China, 510260
China, Helongjiang Province

Harbin, Helongjiang Province, China, 150001
China, Shanxi Province

Xi'an, Shanxi Province, China, 710032

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Beverly Paperiello

Abbott

More Information

Responsible Party:	Abbott Laboratories ( Michael Snyder )
Study ID Numbers:	M04-705
Study First Received:	October 1, 2007
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00538902
Health Authority:	China: State Food and Drug Administration

Keywords provided by Abbott:

Humira, methotrexate

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009