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 not yet open for participant recruitment.
Verified July 2012 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01578850
First received: April 12, 2012
Last updated: July 18, 2012
Last verified: July 2012
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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: | June 2014 |
| Estimated Primary Completion Date: | June 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:
- Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
- 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:
Subjects who used any of the following systemic treatments during the washout periods given below:
- Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
- Treatment with more than 1 NSAID within 14 days at baseline.
- Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
- 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.
- Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
- Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
- Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578850
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Hungary | |
| Budai Irgalmasendi Korhaz, Reumatologia I. | Recruiting |
| Budapest, Hungary, 1027 | |
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 18, 2012 |
| 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 October 17, 2012
