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Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00234845
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : August 29, 2007
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: adalimumab Drug: methotrexate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis
Study Start Date : March 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Job loss measurement

Secondary Outcome Measures :
  1. Job productivity measurements
  2. Patient reported outcomes
  3. DAS28
  4. Safety parameters

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
  • Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
  • Subject must be in paid employment
  • Subject has self-reported work impairment since onset of symptoms

Exclusion Criteria:

  • A subject has chronic arthritis diagnosed before age 16 years.
  • Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
  • Subject has preceding treatment with any biological TNF antagonist
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234845


Locations
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United States, Illinois
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Beverly Paperiello Abbott
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00234845     History of Changes
Other Study ID Numbers: M02-527
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: August 29, 2007
Last Verified: August 2007
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents