Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01578850
First received: April 12, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Etanercept
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Placebo-controlled Study of the Maintenance of Efficacy of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone in Subjects With Rheumatoid Arthritis After Achieving an Adequate Response With Etanercept Plus Dmard(s)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of subjects who remained in low disease activity at Week 52, among those who have achieved it at Week 24. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who remained in remission at Week 52, among those who have achieved remission at Week 24. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects in LDA or remission at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the DAS28 score at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Time-to-flare or loss of efficacy during Period 2. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving European League Against Rheumatism good and or moderate responses at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving LDA or remission at each visit during Period 1 and 2 based on CDAI and SDAI each visit during Period 1 and 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change of CDAI and SDAI at each visit during Period 1 and 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ACR 20, ACR 50, ACR 70 and ACR 90 during Period 1 and Period 2 at each visit. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in the tender and swollen joint counts at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in the Physician Global Assessment at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in the Subject Global Assessment, including morning stiffness (measured in minutes) at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in the Subject General Health visual analog scale, and Pain VAS at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in CRP and ESR at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: Etanercept
etanercept 50mg once weekly + methotrexate with or without other DMARDs
Placebo Comparator: Group B Drug: placebo
etanercept placebo once weekly + methotrexate with or without other DMARDs

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
  2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

Exclusion Criteria:

  1. Subjects who used any of the following systemic treatments during the washout periods given below:

    1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
    2. Treatment with more than 1 NSAID within 14 days at baseline.
    3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
    4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
    5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
  2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
  3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578850

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 62 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01578850     History of Changes
Other Study ID Numbers: B1801315
Study First Received: April 12, 2012
Last Updated: July 22, 2014
Health Authority: South Africa: Medicines Control Council

Keywords provided by Pfizer:
rheumatoid arthritis
etanercept
methotrexate
DMARDs

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
Methotrexate
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on July 28, 2014