Back to resultsOpen-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Total Exposure-Adjusted Rate of Deaths
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
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
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
Malignancy
Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
Lymphoma
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
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
Total Exposure Adjusted Rate of Serious Adverse Events
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
Death
Death of the participant on study up to 30 days after the last dose of etanercept
Secondary Outcome Measures
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)
Dosing Period
Duration of etanercept dosing
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
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
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
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.
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
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
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).
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.
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.
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.
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.
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.
Percent Improvement in C-Reactive Protein From Baseline to Month 12
Percent improvement in C-reactive protein from baseline to month 12
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
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.
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.
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.
Full Information
NCT ID
NCT00356590
First Posted
July 24, 2006
Last Updated
May 10, 2013
Sponsor
Amgen
Collaborators
Immunex Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00356590
Brief Title
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Official Title
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
Immunex Corporation
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
468 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Etanercept
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Exposure to Etanercept With Gaps
Description
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.
Time Frame
Up to 8 years
Title
Total Exposure-Adjusted Rate of Malignancies
Description
Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Time Frame
Up to 8 years
Title
Total Exposure-Adjusted Rate of Deaths
Description
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Time Frame
Up to 8 years
Title
Total Exposure Adjusted Rate of Serious Infectious Events
Description
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
Time Frame
Up to 8 years
Title
Total Exposure Adjusted Rate of Lymphomas
Description
Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Time Frame
Up to 8 years
Title
Malignancy
Description
Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
Time Frame
Up to 8 years
Title
Lymphoma
Description
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Time Frame
Up to 8 years
Title
Serious Infectious Event
Description
Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication
Time Frame
Up to 8 years
Title
Total Exposure Adjusted Rate of Serious Adverse Events
Description
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
Time Frame
Up to 8 years
Title
Death
Description
Death of the participant on study up to 30 days after the last dose of etanercept
Time Frame
Up to 8 years
Secondary Outcome Measure Information:
Title
ACR20 Response at Month 3
Description
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)
Time Frame
Baseline and month 3
Title
Dosing Period
Description
Duration of etanercept dosing
Time Frame
Up to 8 years
Title
ACR20 Response at Month 12
Description
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
Time Frame
Baseline and month 12
Title
ACR50 Response at Month 12
Description
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
Time Frame
Baseline and month 12
Title
ACR70 Response at Month 12
Description
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
Time Frame
Baseline and month 12
Title
Standardized Incidence Rate for All SEER Cancers
Description
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.
Time Frame
Up to 8 years
Title
Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12
Description
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
Time Frame
Baseline and month 12
Title
Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12
Description
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
Time Frame
Baseline and Month 12
Title
Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12
Description
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).
Time Frame
Baseline and month 12
Title
Percent Improvement in Tender Joint Count From Baseline to Month 12
Description
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.
Time Frame
Baseline and month 12
Title
Percent Improvement in Swollen Joint Count From Baseline to Month 12
Description
Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.
Time Frame
Baseline and month 12
Title
Percent Improvement in HAQ DI From Baseline to Month 12
Description
Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.
Time Frame
Baseline and month 12
Title
Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12
Description
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.
Time Frame
Baseline and month 12
Title
Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12
Description
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.
Time Frame
Baseline and month 12
Title
Percent Improvement in C-Reactive Protein From Baseline to Month 12
Description
Percent improvement in C-reactive protein from baseline to month 12
Time Frame
Baseline and month 12
Title
Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12
Description
Percent improvement in the duration of morning stiffness from baseline to month 12
Time Frame
Baseline and month 12
Title
Change From Baseline to Year 2 in Total Sharp Score
Description
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.
Time Frame
Baseline, Year 2
Title
Change From Baseline to Year 2 in Sharp Score Erosion Subscale
Description
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.
Time Frame
Baseline, Year 2
Title
Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale
Description
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.
Time Frame
Baseline, Year 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15996057
Citation
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.
Results Reference
result
PubMed Identifier
12115173
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 radiographic and clinical outcomes. Arthritis Rheum. 2002 Jun;46(6):1443-50. doi: 10.1002/art.10308.
Results Reference
result
PubMed Identifier
20957659
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
We'll reach out to this number within 24 hrs