Moderate Rheumatoid Arthritis (RA) With Enbrel - Full Text View

Purpose

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).

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: etanercept	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of adding 50 mg etanercept per week to standard-of-care DMARD therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	210
Study Start Date:	March 2011
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo 50 mg	Drug: etanercept 50 mg subcutaneous injection once weekly.
Experimental: etanercept 50 mg	Drug: etanercept 50 mg subcutaneous injection once weekly.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313208

Show 47 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01313208 History of Changes
Other Study ID Numbers:	20070561
Study First Received:	March 10, 2011
Last Updated:	March 11, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Amgen:

RA
Enbrel
DMARD
Joint Count

Rheumatoid Arthritis
Etanercept
disease modifying anti-rheumatic drug

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013