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Psoriatic ArthritisPhase 3NCT00317499

Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis

A Phase 3 study testing Etanercept in people with Psoriatic Arthritis and Psoriasis, 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 was a phase 3, double-blind, placebo-controlled, randomized, multicenter study in subjects with psoriatic arthritis (PsA) and psoriasis comprising 3 periods: a 24-week double-blind period, a ≤ 24-week maintenance period, and a 48-week open-label period. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Psoriatic Arthritis, Psoriasis
What is being tested?
Etanercept
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
205 participants
Where
No sites listed yet
Study dates
Apr 2000to Jul 2002
Phase
Phase 3
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Guttate or pustular psoriasis.
  • Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Active severe infection within 1 month of investigational product administration.
  • Subjects must be off antibiotics for 1 week before investigational product administration.
  • Previous receipt of etanercept, known antibody to TNF, or experimental metalloproteinase inhibitors (past or current use of minocycline and doxycycline was acceptable).
  • Receipt of investigational drugs or biologics within 4 weeks of the screening visit.
Show all 26Show fewer
  • Receipt of anti-CD4 or diptheria IL-2 fusion protein within the previous 6 months, with a subsequent abnormal absolute T cell count.
  • Psoralen ultraviolet A phototherapy (PUVA) within 4 weeks of investigational product initiation. Ultraviolet B (UVB) phototherapy within 2 weeks of investigational product initiation.
  • Receipt of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX (eg, hydroxycholorquine, oral or injectable gold, cyclophosphamide, cyclosporine, azathioprine, D-penicillamine, or sulfasalazine) or intra-articular corticosteroids within 4 weeks before the first dose of investigational product.
  • Dose of NSAID greater than the maximum recommended dose in the product information. NSAID dose had to be stable for ≥ 4 weeks before screening evaluation.
  • Concomitant corticosteroids > 10 mg/day of prednisone (or its equivalent). Corticosteroid dose had to be stable for ≥ 4 weeks before screening evaluation.
  • Topical steroids, oral retinoids, topical vitamin A or D analog preparations or anthralin within 14 days of baseline. (Exception: Topical therapies were permitted on scalp, axillae, and groin but had to be stable throughout trial.)
  • Pregnancy or lactation in women.
  • Significant concurrent medical diseases including:
  • Diabetes mellitus requiring insulin
  • Uncompensated congestive heart failure
  • Myocardial infarction within 12 months of screening visit
  • Unstable or stable angina pectoris
  • Uncontrolled hypertension
  • Severe pulmonary disease (requiring medical or oxygen therapy)
  • History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) within 5 years of screening visit
  • HIV positive, hepatitis B surface antigen, or hepatitis C positive
  • Rheumatoid arthritis, systemic lupus, scleroderma, or polymyositis
  • Any condition judged by the subject's physician that would cause this study to be detrimental to the subject
  • Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
  • History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.

About this study

Official title: Double-Blind, Randomized, Placebo-Controlled Study of Etanercept (ENBREL) in the Treatment of Psoriatic Arthritis (PsA) and Psoriasis

This was a phase 3, double-blind, placebo-controlled, randomized, multicenter study in subjects with psoriatic arthritis (PsA) and psoriasis comprising 3 periods: a 24-week double-blind period, a ≤ 24-week maintenance period, and a 48-week open-label period. During the double-blind period, subjects were randomized equally to 1 of 2 regimens: etanercept 25 mg twice weekly (BIW) or placebo, administered subcutaneously (SC). After the week 24 visit, subjects continued on blind-labeled therapy in a maintenance period until all subjects completed the double-blind period. After the maintenance period, all subjects received open-label etanercept 25 mg BIW.

Read the detailed description

Previously presented data from 2 double-blind, placebo-controlled trials (Protocols 016.0612 [Investigator IND] and 016.0030 [Immunex IND]) led to the approval of etanercept for reducing clinical signs and symptoms of PsA. One-year radiographic data from Protocol 20021630 led to an additional approval of etanercept for inhibiting structural progression in PsA.

Data are used for the following purposes:

  • To summarize the clinical efficacy and safety results previously described in the 6-month clinical study report and the radiographic results previously described in the 1-year clinical study report.
  • To show the effect of etanercept on physical function in subjects with PsA and psoriasis, as measured by 2 patient-reported outcome measures (disability index of the Stanford Health Assessment Questionnaire [HAQ] and Medical Outcomes Study Short-form Health Survey [SF-36]). • To present the radiographic results at 2 years from baseline and the final clinical efficacy and safety results during the open-label period of the study.
Being tested
Placebo, Etanercept
Medical subject headings
Arthritis, Psoriatic, Psoriasis

What participants receive

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

Study groups in NCT00317499
Study groupRoleWhat they receive
EtanerceptExperimentalNot described
Receives: Drug: Etanercept
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

Timeline

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

  1. First posted25 Apr 2006 (estimated)
  2. Study startApr 2000
  3. Primary completionJun 2002
  4. Study completionJul 2002

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
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317499
Sponsor's protocol ID
20021630
Status last verified
Dec 2010
First submitted
21 Apr 2006
Last updated
23 Dec 2010
Results posted
No

Publications

  • Mease PJ, Ritchlin CT, Martin RW, Gottlieb AB, Baumgartner SW, Burge DJ, Whitmore JB. Pneumococcal vaccine response in psoriatic arthritis patients during treatment with etanercept. J Rheumatol. 2004 Jul;31(7):1356-61.

    PubMed 15229957

  • Mease PJ, Kivitz AJ, Burch FX, Siegel EL, Cohen SB, Ory P, Salonen D, Rubenstein J, Sharp JT, Tsuji W. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 2004 Jul;50(7):2264-72. doi: 10.1002/art.20335.

    PubMed 15248226

  • Mease PJ, Kivitz AJ, Burch FX, Siegel EL, Cohen SB, Ory P, Salonen D, Rubenstein J, Sharp JT, Dunn M, Tsuji W. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006 Apr;33(4):712-21. Epub 2006 Feb 1.

    PubMed 16463435

  • Bansback NJ, Ara R, Barkham N, Brennan A, Fraser AD, Conway P, Reynolds A, Emery P. Estimating the cost and health status consequences of treatment with TNF antagonists in patients with psoriatic arthritis. Rheumatology (Oxford). 2006 Aug;45(8):1029-38. doi: 10.1093/rheumatology/kel147. Epub 2006 Jun 16.

    PubMed 16782734

  • Mease PJ, Woolley JM, Singh A, Tsuji W, Dunn M, Chiou CF. Patient-reported outcomes in a randomized trial of etanercept in psoriatic arthritis. J Rheumatol. 2010 Jun;37(6):1221-7. doi: 10.3899/jrheum.091093. Epub 2010 Apr 15.

    PubMed 20395648

  • Mease PJ, Woolley JM, Bitman B, Wang BC, Globe DR, Singh A. Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-rated importance and satisfaction. J Rheumatol. 2011 Nov;38(11):2461-5. doi: 10.3899/jrheum.110546. Epub 2011 Sep 1.

    PubMed 21885498

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etanercept in people with Psoriatic Arthritis and Psoriasis, 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?

The sponsor lists 0 inclusion and 26 exclusion criteria. 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 23 Dec 2010. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00317499, which also lists 6 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 23 Dec 2010.

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