Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012

Rheumatoid Arthritis Clinical Trial

Official title:

Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356590
• Other study ID #: 20021623
• Secondary ID: 16.0023
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2006
• Last updated: May 10, 2013
• Start date: December 1998
• Est. completion date: April 2009

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug AdministrationUnited States: Western Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Etanercept
Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Immunex Corporation

References & Publications (2)

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. — View 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 — 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, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.	Up to 8 years	No
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 8 years	Yes
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 8 years	Yes
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 8 years	Yes
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 8 years	Yes
Primary	Malignancy	Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept	Up to 8 years	Yes
Primary	Lymphoma	Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept	Up to 8 years	Yes
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	Up to 8 years	Yes
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 8 years	Yes
Primary	Death	Death of the participant on study up to 30 days after the last dose of etanercept	Up to 8 years	No
Secondary	ACR20 Response at Month 3	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 (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)	Baseline and month 3	No
Secondary	Dosing Period	Duration of etanercept dosing	Up to 8 years	No
Secondary	ACR20 Response at Month 12	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 12	No
Secondary	ACR50 Response at Month 12	American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults	Baseline and month 12	No
Secondary	ACR70 Response at Month 12	American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults	Baseline and month 12	No
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, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.	Up to 8 years	No
Secondary	Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12	Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms	Baseline and month 12	No
Secondary	Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12	Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms	Baseline and Month 12	No
Secondary	Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12	Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm).	Baseline and month 12	No
Secondary	Percent Improvement in Tender Joint Count From Baseline to Month 12	Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.	Baseline and month 12	No
Secondary	Percent Improvement in Swollen Joint Count From Baseline to Month 12	Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.	Baseline and month 12	No
Secondary	Percent Improvement in HAQ DI From Baseline to Month 12	Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.	Baseline and month 12	No
Secondary	Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12	Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.	Baseline and month 12	No
Secondary	Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12	Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.	Baseline and month 12	No
Secondary	Percent Improvement in C-Reactive Protein From Baseline to Month 12	Percent improvement in C-reactive protein from baseline to month 12	Baseline and month 12	No
Secondary	Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12	Percent improvement in the duration of morning stiffness from baseline to month 12	Baseline and month 12	No
Secondary	Change From Baseline to Year 2 in Total Sharp Score	Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.	Baseline, Year 2	No
Secondary	Change From Baseline to Year 2 in Sharp Score Erosion Subscale	Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.	Baseline, Year 2	No
Secondary	Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale	Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.	Baseline, Year 2	No

External Links

•   AmgenTrials clinical trials website