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

NCT00357903 | Completed Phase 3 Results

• 2 other identifiers: 2002161816.0018
• Study Type: interventional
• Target: 639
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel

Outcome Measures

Primary Outcomes (10)

• Total Exposure to Etanercept With Gaps

  Total participant exposure to etanercept (Enbrel) with gaps

  Up to 10 years

• 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

• 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

• 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

• 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

• Malignancy

  Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept

  Up to 10 years

• Lymphoma

  Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept

  Up to 10 years

• 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

• Death

  Occurrence of death on study within 30 days of the last dose of etanercept

  Up to 10 years

• 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 Outcomes (9)

• Dosing Period

  Up to 10 years

• Tender Joint Count

  Month 12

• Swollen Joint Count

  Month 12

• Health Assessment Questionnaire Disability Index

  Month 12

• Childhood Health Assessment Questionnaire

  Month 12

Study Arms (1)

1

OTHER

Biological: Etanercept

Interventions

Etanercept BIOLOGICAL

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).

1

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead
• Immunex Corporation: collaborator

Related Publications (10)

• 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.

  PMID: 12672185 BACKGROUND

• 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. doi: 10.1002/art.11142.

  PMID: 12794815 BACKGROUND

• 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. doi: 10.1002/art.10710.

  PMID: 12528122 BACKGROUND

• 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.

  PMID: 18438876 BACKGROUND

• 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. doi: 10.1002/art.21885.

  PMID: 16732547 BACKGROUND

• 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. doi: 10.1006/clim.2001.5183.

  PMID: 11987981 BACKGROUND

• 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.

  PMID: 11409115 BACKGROUND

• 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. Epub 2006 Mar 15.

  PMID: 16541481 BACKGROUND

• 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. doi: 10.1002/1529-0131(200105)44:53.0.CO;2-F.

  PMID: 11352248 BACKGROUND

• 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.

  PMID: 20957659 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 28, 2006
• Study Start: April 1, 1997
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: February 9, 2017
• Results First Posted: December 6, 2010

Record last verified: 2017-02