Quality of Life Study With Adalimumab in Rheumatoid Arthritis - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00234936

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 III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Quality of Life Study With Adalimumab in Rheumatoid Arthritis

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

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

Keywords provided by Abbott:

rheumatoid arthritis
adalimumab
quality of life

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases

Arthritis, Rheumatoid
Methotrexate
Quality of Life
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