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Moderate Rheumatoid Arthritis (RA) With Enbrel

Information source: Amgen
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: etanercept (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Overall contact:
Amgen Call Center, Phone: 866-572-6436

Summary

This study is designed to evaluate the effectiveness of adding Etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in subjects with moderately active Rheumatoid Arthritis (RA).

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To evaluate whether adding 50 mg etanercept per week to standard-of-care DMARD therapy in subjects with moderately active Rheumatoid Arthritis is superior in inducing very good control of disease compared with continued DMARD therapy

Secondary outcome:

To evaluate the safety of adding 50 mg etanercept per week to standard-of-care DMARD therapy

To evaluate the effect of adding 50 mg etanercept per week to standard-of-care DMARD therapy in subjects with moderately active rheumatoid arthritis on the following parameters: * disease activity measures * quality of life and health-related outcomes

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female ≥18 and ≤80 years of age at time of screening

- Subject is diagnosed with rheumatoid arthritis as determined by meeting 1987 American

College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months

- Subject has moderate rheumatoid arthritis during screening, as defined by a DAS28-CRP

> 3. 2 and ≤ 5. 1

- Subject has active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28

joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees)

- Subject must be currently taking a DMARD such as methotrexate, sulfasalazine,

leflunomide, minocycline, and/or hydroxychloroquine

Exclusion Criteria:

- Subject had prosthetic joint infection within 5 years of screening or native joint

infection within 1 year of screening

- Subject has Class IV rheumatoid arthritis according to ACR revised response criteria

- Subject has any active infection (including chronic or localized infections) for

which anti-infectives were indicated within 28 days prior to first investigational product dose

- Subject has previously used more than one experimental biologic DMARD. Subject with

prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product

- Subject has previously used more than one commercially available biologic DMARD.

Subject with prior use of no more than one commercially available biologic is permitted if the subject received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples:

- No more than 4 injections of adalimumab

- No more than 8 (50 mg) injections of etanercept

- No more than 2 infusions of infliximab

- No more than 2 infusions of abatacept

- Additional inclusion (exclusion) criteria may apply

Locations and Contacts

Amgen Call Center, Phone: 866-572-6436

Research Site, Quebec G1V 3M7, Canada; Recruiting

Research Site, Birmingham, Alabama 35205, United States; Completed

Research Site, Tuscaloosa, Alabama 35406, United States; Recruiting

Research Site, Peoria, Arizona 85381, United States; Recruiting

Research Site, Scottsdale, Arizona 85258, United States; Recruiting

Research Site, Encino, California 91436, United States; Recruiting

Research Site, Hemet, California 92543, United States; Recruiting

Research Site, Inglewood, California 90301, United States; Recruiting

Research Site, La Jolla, California 92037, United States; Recruiting

Research Site, Murrieta, California 92563, United States; Recruiting

Research Site, Santa Maria, California 93454, United States; Recruiting

Research Site, Tustin, California 92780, United States; Recruiting

Research Site, Upland, California 91786, United States; Recruiting

Research Site, Victorville, California 92395, United States; Recruiting

Research Site, Denver, Colorado 80230, United States; Recruiting

Research Site, Jacksonville, Florida 32209, United States; Recruiting

Research Site, Ocala, Florida 34474, United States; Recruiting

Research Site, Sarasota, Florida 34239, United States; Recruiting

Research Site, Sebring, Florida 33870, United States; Completed

Research Site, Tampa, Florida 33613, United States; Recruiting

Research Site, Atlanta, Georgia 30342, United States; Recruiting

Research Site, Meridian, Idaho 83642, United States; Recruiting

Research Site, Springfield, Illinois 62704, United States; Recruiting

Research Site, Lexington, Kentucky 40504, United States; Recruiting

Research Site, Winnipeg, Manitoba R3A 1M3, Canada; Recruiting

Research Site, Frederick, Maryland 21702, United States; Recruiting

Research Site, Lansing, Michigan 48910, United States; Recruiting

Research Site, St. Clair Shores, Michigan 48081, United States; Recruiting

Research Site, St. John's, Newfoundland and Labrador A1C 5B8, Canada; Recruiting

Research Site, Bismarck, North Dakota 58501, United States; Recruiting

Research Site, Akron, Ohio 44311, United States; Recruiting

Research Site, Mayfield Village, Ohio 44143, United States; Recruiting

Research Site, Oklahoma City, Oklahoma 73109, United States; Completed

Research Site, Oklahoma City, Oklahoma 73103, United States; Recruiting

Research Site, Burlington, Ontario L7R 1E2, Canada; Recruiting

Research Site, Portland, Oregon 97239, United States; Recruiting

Research Site, Erie, Pennsylvania 16508, United States; Recruiting

Research Site, Laval, Quebec H7T 2P5, Canada; Completed

Research Site, Montreal, Quebec H2L 1S6, Canada; Recruiting

Research Site, Montreal, Quebec H3Z 2Z3, Canada; Completed

Research Site, Montreal, Quebec H1T 2M4, Canada; Completed

Research Site, Saint-Eustache, Quebec J7P 4J2, Canada; Completed

Research Site, Greer, South Carolina 29650, United States; Recruiting

Research Site, Dallas, Texas 75231, United States; Recruiting

Research Site, San Antonio, Texas 78232, United States; Recruiting

Research Site, Chesapeake, Virginia 23320, United States; Recruiting

Research Site, Seattle, Washington 98133, United States; Completed

Additional Information

AmgenTrials clinical trials website

Starting date: March 2011
Last updated: January 25, 2013

Page last updated: February 07, 2013

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