Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis (RA) Subjects Who Are Sub-Optimal Responders to Etanercept 50 mg Once Weekly (QW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00115219
First received: June 21, 2005
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The purpose of this study objective will be to evaluate the efficacy and safety of etanercept 50 mg BIW in RA subjects who showed a sub-optimal response to standard dose etanercept (50 mg QW) and concomitant methotrexate therapy.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-Blind, Active-Controlled Study Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis Subjects Who Are Sub-optimal Responders to Etanercept 50 mg Once Weekly (QW)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12

Secondary Outcome Measures:
  • Proportion of subjects who achieve American College of Rheumatology (ACR) 20, 50, and 70 responses at Weeks 12 and 24
  • Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria at Week 24 and the proportion achieving clinical remission (DAS28<2.6) at Weeks 12 and 24
  • Changes from baseline with respect to the DAS28 score and ACR score (including HAQ) criteria at Weeks 12 and 24
  • Changes from baseline in patient-reported outcomes as measured by the SF-36 at Weeks 12 and 24
  • Proportion of etanercept 50mg BIW responders at Week 12 who mantain a clinical improvement with etanercept 50mg QW (defined as no DAS28 increase of greater than 0.6 from Week 12) at Week 24
  • Safety (SAEs and AEs) in three study periods (4-week open label run-in period, 12-week double blinded period A, and 12-week open-label period B)

Estimated Enrollment: 200
Study Start Date: May 2005
  Eligibility

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

Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis
  • RA with a disease duration > 6 months
  • Current and prior but continuous etanercept (50 mg weekly) treatment for at least 5 months prior to screening
  • Subjects must be receiving methotrexate (MTX) at a stable dose > 15 mg/week at least 4 weeks prior to screening
  • Sub-optimal response to etanercept defined by the presence of the following criteria (based on 28 joint count) at screening: 5 or more swollen joints and 5 or more tender joints
  • Subjects who are currently receiving oral corticosteroids must be on a dose equivalent to prednisone less than or equal to 10 mg/day at screening
  • Subjects who are currently receiving non-steroidal anti-inflammatory drugs (NSAIDs), must be on a stable dose for at least 2 weeks prior to screening
  • Subjects who are currently receiving DMARD therapy (including sulfasalazine, hydroxy-chloroquine and leflunomide), must be on a stable dose for at least 4 weeks prior to screening

Exclusion Criteria:

  • Nursing mothers, female subjects planning on becoming pregnant, or male subjects planning a pregnancy with their spouse/partner while in the study
  • ACR functional class IV
  • Receipt of any investigational drug or biologic within 4 weeks of study drug initiation
  • Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent
  • History of alcohol or drug abuse within 12 months of screening visit
  • Severe comorbidities including: History of cancer (other than resected cutaneous basal and squamous cell carcinoma, and in situ cervical cancer) within 5 years of screening visit. Documentation of disease-free state since treatment required; Diagnosis of Class III or IV congestive heart failure (CHF) or myocardial infarction (MI) within 12 months of screening; Unstable or stable angina pectoris; Uncontrolled hypertension (defined as systolic blood pressure measurement of greater than 180 mm Hg or a diastolic blood pressure of greater than 110 mm Hg); Oxygen-dependent pulmonary disease; Known HIV-positive status or other immunodeficiency syndromes; Chronic hepatitis B (HbsAg) or C (HCV); Systemic lupus erythematosus (SLE); CNS demyelinating events suggestive of multiple sclerosis; Presence of active infection or any underlying diseases that could predispose subjects to infection (e.g., history of recurrent infections, non-healing leg ulcers, advanced or poorly controlled diabetes); Active or prior history of tuberculosis (or known exposure).
  • Concurrent treatment with cyclophosphamide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115219

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00115219     History of Changes
Other Study ID Numbers: 20040275
Study First Received: June 21, 2005
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Rheumatoid Arthritis, RA
Enbrel® (etanercept)
Clinical Trials, Amgen
Immunex, Methotrexate (MTX)
Rheumatoid Arthritis (RA)

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

ClinicalTrials.gov processed this record on April 15, 2014