Open-Label Extension Treatment With TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials - Full Text View

Sponsors and Collaborators:	Amgen Immunex Corporation
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00357903

Purpose

This study was designed to provide all adult and pediatric arthritis patients (placebo and TNFR:Fc treated) who have participated in clinical trials with TNFR:Fc the opportunity to receive continued treatment with TNFR:Fc.

The primary objective of this study is to examine safety parameters.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: Etanercept	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Open-Label Extension Treatment With TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

To evaluate long term safety of TNFR:Fc in various patient populations with rheumatoid arthritis. Improvement in core components of the ACR response, and quality of life will be determined. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate long term biologic activity of TNFR:Fc in various patient populations with rheumatoid arthritis. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment:	639
Study Start Date:	April 1997
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 N/A	Biological: Etanercept Adult RA patients on TNFR:Fc with well controlled arthritic symptoms will continue on the TNFR:Fc dose administered int heir 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).

Arms

Assigned Interventions

1

N/A

Biological: Etanercept

Adult RA patients on TNFR:Fc with well controlled arthritic symptoms will continue on the TNFR:Fc dose administered int heir 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).

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Previous enrollment in Immunex protocols

No clinically significant adverse events thought to be due to 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 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 TNFR:Fc in this study.
Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of TNFR:Fc in this study.
Receipt of cyclophosphamide within six months prior to the first dose of TNFR:Fc in this study.
Receipt of cyclosporin within two weeks prior to the first dose of TNFR:Fc in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357903

Show 40 Study Locations

Sponsors and Collaborators

Amgen

Immunex Corporation

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20021618, 16.0018
Study First Received:	July 26, 2006
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00357903 History of Changes
Health Authority:	United States: Western Institutional Review Board; Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Amgen:

Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel

Study placed in the following topic categories:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009