Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357903
• Other study ID #: 20021618
• Secondary ID: 16.0018
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2006
• Last updated: February 7, 2017
• Start date: April 1997
• Est. completion date: April 2009

Study information

• Verified date: February 2017
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Etanercept
Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Immunex Corporation

References & Publications (9)

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

Outcome

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

External Links

•   AmgenTrials clinical trials website