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

This study has been completed.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00234845

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: adalimumab Drug: methotrexate	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, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott:

Primary Outcome Measures:

Job loss measurement

Secondary Outcome Measures:

Job productivity measurements
Patient reported outcomes
DAS28
Safety parameters

Enrollment:	148
Study Start Date:	March 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-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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234845

Locations

United States, Illinois
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Beverly Paperiello

Abbott

More Information

Study ID Numbers:	M02-527
Study First Received:	September 13, 2005
Last Updated:	August 28, 2007
ClinicalTrials.gov Identifier:	NCT00234845
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

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