Rheumatoid Arthritis Clinical Trial
Official title:
Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials
Verified date | February 2017 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.
Status | Completed |
Enrollment | 639 |
Est. completion date | April 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility |
Inclusion Criteria: - Previous enrollment in Immunex protocols - 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 TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. - Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study. - Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. - Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study. - Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amgen | Immunex Corporation |
Fleischmann RM, Baumgartner SW, Tindall EA, Weaver AL, Moreland LW, Schiff MH, Martin RW, Spencer-Green GT. Response to etanercept (Enbrel) in elderly patients with rheumatoid arthritis: a retrospective analysis of clinical trial results. J Rheumatol. 2003 Apr;30(4):691-6. — View Citation
Kremer JM, Weinblatt ME, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Jackson CG, Atkins KM, Feng A, Burge DJ. Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis: continued observations. Arthritis Rheum. 2003 Jun;48(6):1493-9. — View Citation
Lovell DJ, Giannini EH, Reiff A, Jones OY, Schneider R, Olson JC, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Lange M, Finck BK, Burge DJ; Pediatric Rheumatology Collaborative Study Group.. Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis Rheum. 2003 Jan;48(1):218-26. — View Citation
Lovell DJ, Reiff A, Ilowite NT, Wallace CA, Chon Y, Lin SL, Baumgartner SW, Giannini EH; Pediatric Rheumatology Collaborative Study Group.. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum. 2008 May;58(5):1496-504. doi: 10.1002/art.23427. — View Citation
Lovell DJ, Reiff A, Jones OY, Schneider R, Nocton J, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore JB, White B, Giannini EH; Pediatric Rheumatology Collaborative Study Group.. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006 Jun;54(6):1987-94. — View Citation
Moreland LW, Bucy RP, Weinblatt ME, Mohler KM, Spencer-Green GT, Chatham WW. Immune function in patients with rheumatoid arthritis treated with etanercept. Clin Immunol. 2002 Apr;103(1):13-21. — View Citation
Moreland LW, Cohen SB, Baumgartner SW, Tindall EA, Bulpitt K, Martin R, Weinblatt M, Taborn J, Weaver A, Burge DJ, Schiff MH. Long-term safety and efficacy of etanercept in patients with rheumatoid arthritis. J Rheumatol. 2001 Jun;28(6):1238-44. — View Citation
Moreland LW, Weinblatt ME, Keystone EC, Kremer JM, Martin RW, Schiff MH, Whitmore JB, White BW. Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience. J Rheumatol. 2006 May;33(5):854-61. — View Citation
Stone JH, Uhlfelder ML, Hellmann DB, Crook S, Bedocs NM, Hoffman GS. Etanercept combined with conventional treatment in Wegener's granulomatosis: a six-month open-label trial to evaluate safety. Arthritis Rheum. 2001 May;44(5):1149-54. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Exposure to Etanercept With Gaps | Total participant exposure to etanercept (Enbrel) with gaps | Up to 10 years | |
Primary | Total Exposure Adjusted Rate of Malignancies | Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept | Up to 10 years | |
Primary | Total Exposure Adjusted Rate of Deaths | Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept | Up to 10 years | |
Primary | Total Exposure Adjusted Rate of Serious Infectious Events | Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept | Up to 10 years | |
Primary | Total Exposure Adjusted Rate of Lymphomas | Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept | Up to 10 years | |
Primary | Malignancy | Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept | Up to 10 years | |
Primary | Lymphoma | Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept | Up to 10 years | |
Primary | Serious Infectious Event | Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious. | Up to 10 years | |
Primary | Death | Occurrence of death on study within 30 days of the last dose of etanercept | Up to 10 years | |
Primary | Total Exposure Adjusted Rate of Serious Adverse Events | Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100) | Up to 10 years | |
Secondary | Dosing Period | Duration of etanercept dosing | Up to 10 years | |
Secondary | Tender Joint Count | Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation | Month 12 | |
Secondary | Swollen Joint Count | Number of swollen joints | Month 12 | |
Secondary | Health Assessment Questionnaire Disability Index | Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function). | Month 12 | |
Secondary | Childhood Health Assessment Questionnaire | Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do). | Month 12 | |
Secondary | C-Reactive Protein | C-reactive protein at month 12 | Month 12 | |
Secondary | ACR20 at Month 3 in Adults | American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults | Baseline and month 3 | |
Secondary | JRA DOI 30 at Month 3 in Juveniles | Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items. | Baseline and month 3 | |
Secondary | Standardized Incidence Rate for All SEER Cancers | Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system. | up to 10 years |
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