Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00647920
First received: March 28, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate


Condition Intervention Phase
Rheumatoid Arthritis
Biological: adalimumab
Biological: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Human Anti-TNF-Antibody Adalimumab

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • ACR20 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ACR50 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • ACR70 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: July 2003
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg Biological: adalimumab
40 mg adalimumab sc, every other week
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Placebo Comparator: Placebo Biological: placebo
placebo sc, every other week
Other Name: Placebo

  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 screening and baseline visits 6 swollen joints and 9 tender joints.

Exclusion Criteria:

  • A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647920

Locations
Taiwan
Taichung, Taiwan
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Michael Snyder/Clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00647920     History of Changes
Other Study ID Numbers: M02-573
Study First Received: March 28, 2008
Last Updated: March 28, 2008
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014