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Rheumatoid ArthritisPhase 3NCT00356590

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

A Phase 3 study testing Etanercept in people with Rheumatoid Arthritis, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Etanercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
468 participants
Where
No sites listed yet
Study dates
Dec 1998to Apr 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

About this study

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.

Being tested
Etanercept
Keywords
Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptBiological

    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.

Study groups in NCT00356590
Study groupRoleWhat they receive
1OtherNot described
Receives: Biological: Etanercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 8 years

  2. 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

    Measured: Up to 8 years

  3. Total Exposure-Adjusted Rate of Deaths

    Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept

    Measured: Up to 8 years

  4. 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

    Measured: Up to 8 years

  5. 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

    Measured: Up to 8 years

  6. Malignancy

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

    Measured: Up to 8 years

  7. Lymphoma

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

    Measured: Up to 8 years

  8. 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

    Measured: Up to 8 years

  9. Total Exposure Adjusted Rate of Serious Adverse Events

    Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)

    Measured: Up to 8 years

  10. Death

    Death of the participant on study up to 30 days after the last dose of etanercept

    Measured: Up to 8 years

Secondary outcomes (19)

  1. 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)

    Measured: Baseline and month 3

  2. Dosing Period

    Duration of etanercept dosing

    Measured: Up to 8 years

  3. 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

    Measured: Baseline and month 12

  4. 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

    Measured: Baseline and month 12

  5. 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

    Measured: Baseline and month 12

  6. 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.

    Measured: Up to 8 years

  7. 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

    Measured: Baseline and month 12

  8. 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

    Measured: Baseline and Month 12

  9. 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).

    Measured: Baseline and month 12

  10. 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.

    Measured: Baseline and month 12

  11. 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.

    Measured: Baseline and month 12

  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.

    Measured: Baseline and month 12

  13. 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.

    Measured: Baseline and month 12

  14. 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.

    Measured: Baseline and month 12

  15. Percent Improvement in C-Reactive Protein From Baseline to Month 12

    Percent improvement in C-reactive protein from baseline to month 12

    Measured: Baseline and month 12

  16. 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

    Measured: Baseline and month 12

  17. 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.

    Measured: Baseline, Year 2

  18. 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.

    Measured: Baseline, Year 2

  19. 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.

    Measured: Baseline, Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2006 (estimated)
  2. Study startDec 1998
  3. Primary completionDec 2008
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
468 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00356590
Sponsor's protocol ID
20021623
Other IDs
16.0023
Status last verified
May 2013
First submitted
24 Jul 2006
Last updated
14 May 2013

Publications

  • 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.

    PubMed 15996057

  • 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.

    PubMed 12115173

  • 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.

    PubMed 20957659

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etanercept in people with Rheumatoid Arthritis, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Exposure to Etanercept With Gaps (time frame: Up to 8 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356590, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.

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