Clinical trial NCT00356590: Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Official title: Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Etanercept
Long-term Safety
Enbrel
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
First posted: 2006-07-26
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria: - Previous enrollment in Immunex protocol 016.0012.

* No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment.
* Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential.
* No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria:
* Previous receipt of etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
* Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within interval between study drug in 016.0012 and this study.
* Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
* Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.

Primary outcomes:
measure: Total Exposure to Etanercept With Gaps
timeFrame: Up to 8 years
measure: Total Exposure-Adjusted Rate of Malignancies
timeFrame: Up to 8 years
measure: Total Exposure-Adjusted Rate of Deaths
timeFrame: Up to 8 years
measure: Total Exposure Adjusted Rate of Serious Infectious Events
timeFrame: Up to 8 years
measure: Total Exposure Adjusted Rate of Lymphomas
timeFrame: Up to 8 years
measure: Malignancy
timeFrame: Up to 8 years
measure: Lymphoma
timeFrame: Up to 8 years
measure: Serious Infectious Event
timeFrame: Up to 8 years
measure: Total Exposure Adjusted Rate of Serious Adverse Events
timeFrame: Up to 8 years
measure: Death
timeFrame: Up to 8 years
Secondary outcomes:
measure: ACR20 Response at Month 3
timeFrame: Baseline and month 3
measure: Dosing Period
timeFrame: Up to 8 years
measure: ACR20 Response at Month 12
timeFrame: Baseline and month 12
measure: ACR50 Response at Month 12
timeFrame: Baseline and month 12
measure: ACR70 Response at Month 12
timeFrame: Baseline and month 12
measure: Standardized Incidence Rate for All SEER Cancers
timeFrame: Up to 8 years
measure: Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Percent Improvement in Tender Joint Count From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Percent Improvement in Swollen Joint Count From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Percent Improvement in HAQ DI From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Percent Improvement in C-Reactive Protein From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12
timeFrame: Baseline and month 12
measure: Change From Baseline to Year 2 in Total Sharp Score
timeFrame: Baseline, Year 2
measure: Change From Baseline to Year 2 in Sharp Score Erosion Subscale
timeFrame: Baseline, Year 2
measure: Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale
timeFrame: Baseline, Year 2
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, Martin RW, Whitmore JB, Tsuji WH, Leff JA. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005 Jul;32(7):1232-42.
citation: Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Cannon GW, Spencer-Green G, Finck BK. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002 Jun;46(6):1443-50. doi: 10.1002/art.10308.
citation: Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011 Mar;63(3):373-82. doi: 10.1002/acr.20372. Epub 2010 Oct 18.