Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate Rheumatoid Arthritis (RA) Subjects - Full Text View

Purpose

To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: etanercept (EnbrelTM) Drug: methotrexate Drug: disease-modifying anti-rheumatic drug (DMARDs) (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold)	Phase IV

MedlinePlus related topics:

Rheumatoid Arthritis

Drug Information available for:

Methotrexate Cyclosporine Cyclosporin Etanercept Hydroxychloroquine Hydroxychloroquine sulfate Sulfasalazine Leflunomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate the impact of ETN + MTX in comparison with usual treatment on radiographic disease progression in subject with moderate RA, who failed treatment with MTX [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare the effects of ETN + MTX and usual treatment on clinical outcomes , health-related quality of life, and safety [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	700
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: etanercept (EnbrelTM) Drug: methotrexate
B: Active Comparator	Drug: disease-modifying anti-rheumatic drug (DMARDs) (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion Criteria:

Previous treatment with ETN, infliximab, adalimumab, other TNF -a inhibitors, anakinra or other biological agents.
Previous combination DMARD therapy
Receipt of any DMARD, other than MTX, within 28 days before screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706797

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881X1-4437
First Received:	June 25, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00706797
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Wyeth:

Moderate Rheumatoid Arthritis

Study placed in the following topic categories:

Autoimmune Diseases

Cyclosporine

Clotrimazole

Miconazole

Joint Diseases

Sulfasalazine

Leflunomide

Tioconazole

Arthritis, Rheumatoid

Rheumatic Diseases

TNFR-Fc fusion protein

Cyclosporins

Folic Acid

Musculoskeletal Diseases

Arthritis

Hydroxychloroquine

Connective Tissue Diseases

Methotrexate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antimetabolites

Anti-Infective Agents

Antiprotozoal Agents

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Reproductive Control Agents

Antimalarials

Antiparasitic Agents

Sensory System Agents

Therapeutic Uses

Antifungal Agents

Abortifacient Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Dermatologic Agents

Nucleic Acid Synthesis Inhibitors

Immune System Diseases

Gastrointestinal Agents

Enzyme Inhibitors

Abortifacient Agents, Nonsteroidal

Folic Acid Antagonists

Immunosuppressive Agents

Pharmacologic Actions

Analgesics, Non-Narcotic

Peripheral Nervous System Agents

Antirheumatic Agents

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00706797