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Quality of Life Study With Adalimumab in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234936
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : October 3, 2007
Information provided by:

Brief Summary:
The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Adalimumab Drug: Methotrexate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quality of Life Study With Adalimumab in Rheumatoid Arthritis
Study Start Date : December 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Primary Outcome Measures :
  1. QOL [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Patient reported outcomes
  2. Clinical response indicators
  3. Safety parameters

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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 ACR criteria
  • Subjects with treatment failure criteria to Mtx or Mtx + another DMARD

Exclusion Criteria:

  • 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
  • Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months

Information from the National Library of Medicine

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 identifier (NCT number): NCT00234936

Sponsors and Collaborators
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Study Director: Global Medical Information Abbott

Layout table for additonal information Identifier: NCT00234936     History of Changes
Other Study ID Numbers: MEXI -P01-03
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: October 3, 2007
Last Verified: October 2007
Keywords provided by Abbott:
rheumatoid arthritis
quality of life
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
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