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Quality of Life Study With Adalimumab in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234936
First received: September 16, 2005
Last updated: October 2, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Drug: Adalimumab
Drug: Methotrexate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • QOL [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Patient reported outcomes
  • Clinical response indicators
  • Safety parameters

Enrollment: 200
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234936

Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234936     History of Changes
Other Study ID Numbers: MEXI -P01-03, ESCALAR
Study First Received: September 16, 2005
Last Updated: October 2, 2007
Health Authority: Mexico: Ministry of Health

Keywords provided by Abbott:
rheumatoid arthritis
adalimumab
quality of life

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 19, 2013