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Arthritis, PsoriaticPhase 3GO-REVEALNCT00265096

A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis

A Phase 3 study testing golimumab in people with Arthritis, Psoriatic, run by Centocor, Inc. at 51 sites in 6 countries.

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

The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
golimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
407 participants
Where
51 sitesin 6 countries
Study dates
Dec 2005to Jan 2012
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

Who may be able to join

  • Psoriatic arthritis (PsA) diagnosed > 6months prior
  • Active PsA at the time of screening and at baseline visits, with >= 3 swollen joints and >= 3 tender joints
  • Have at least 1 of the PsA subsets (DIP joint arthritis, polyarticular arthritis without rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis)
  • Active plaque psoriasis with a lesion >= 2cm in diameter
  • Active arthritis despite current disease modifying anti-rheumatic drug (DMARD) or nonsteroidal anti-inflammatory drug (NSAID) therapy
  • Stable doses of methotrexate, low-dose corticosteroids, and NSAIDs are permitted.

Who cannot join

  • No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)
  • No treatment with alefacept or efalizumab within 3 months prior to the first study drug injection
  • No DMARDs other than methotrexate, or immunosuppressive drugs within 4 weeks prior to the first study drug injection.

Trial locations and contacts

51 sites in 6 countries.

51 sites in 6 countries

United States18 sites

  • Study site

    Aventura, Florida

  • Study site

    Cincinnati, Ohio

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Edmonds, Washington

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Kansas City, Kansas

  • Study site

    La Jolla, California

  • Study site

    Lake Oswego, Oregon

  • Study site

    Mayfield, Ohio

  • Study site

    Omaha, Nebraska

  • Study site

    Portland, Oregon

  • Study site

    Seattle, Washington

  • Study site

    Upland, California

  • Study site

    West Reading, Pennsylvania

  • Study site

    Wheaton, Maryland

  • Study site

    Worcester, Massachusetts

Other trials in United States

Canada15 sites

  • Study site

    Claire

  • Study site

    Hamilton Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Newmarket

  • Study site

    North Bay, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Sainte-Foy, Quebec

  • Study site

    Sante Foy, Quebec

  • Study site

    Saskatoon

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver

  • Study site

    Victoria, British Columbia

  • Study site

    Waterloo, Ontario

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Poland7 sites

  • Study site

    Bialystok

  • Study site

    Elblag

  • Study site

    Kalisz

  • Study site

    Poznan

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Warsaw

Other trials in Poland

Belgium5 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Merksem

Other trials in Belgium

United Kingdom4 sites

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Middlesbrough

  • Study site

    Wigan

Other trials in United Kingdom

Spain2 sites

  • Study site

    Santiago de Compostela

  • Study site

    Valencia

Other trials in Spain

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously in Subjects With Active Psoriatic Arthritis

The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life.

Read the detailed description

Anti-tumor necrosis factor (TNF) agents have been shown to be effective in improving arthritis and psoriasis symptoms in patients with active psoriatic arthritis. Golimumab is a new anti-TNFa agent. This is a multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled, parallel group study comparing safety and efficacy of golimumab 50mg, golimumab 100mg, and placebo subcutaneous injections administered every 4 weeks, in subjects with active PsA. The total duration of treatment is approximately 5 years. In the first portion of the study, some patients will be randomly assigned to receive placebo treatment through the Week 20 injection; others will be assigned to golimumab 50mg or golimumab 100mg groups through the Week 20 injection. There is an "early escape" at Week 16 in the study whereby patients who meet criteria for minimal improvement in their joints will be switched to golimumab if they were on placebo, or have the golimumab dose increased if they were originally assigned to the golimumab 50mg group. At Week 24, the placebo group subjects will switch to golimumab 50mg injections, and all patients will continue receiving in a blinded manner either 50 or 100mg golimumab injections every 4 weeks until the first 52 weeks of data are fully collected on all the subjects (database lock). After this 52-week database lock, everyone will be unblinded to the golimumab dose, and continue to receive golimumab treatment through Week 252 as part of a long-term extension phase of the study, with options for adjusting concomitant PsA medications and/or increasing the dose of golimumab. The study hypothesis is that golimumab will be more effective than placebo both in terms of reducing the signs and symptoms of PsA, as measured by the American College of Rheumatology (ACR) 20 response at Week 14, and inhibiting the amount of damage due to PsA seen on x-rays of the hand and feet at Week 24, while maintaining an acceptable safety profile. Golimumab 50mg, Golimumab 100mg, or placebo injected under the skin every 4 weeks at Weeks 0, 4, 8, 12, 16, and 20, followed by injections of either Golimumab 50mg or Golimumab 100mg every 4 weeks, for approximately 5 years total duration from the time of the first study agent injection.

Being tested
golimumab, Placebo; golimumab
Keywords
Psoriatic Arthritis, Spondyloarthritis, Spondyloarthropathy, subcutaneous injection
Medical subject headings
Arthritis, Psoriatic, Spondylarthritis, Spondylarthropathies

What participants receive

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

  • golimumabBiological

    50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg

  • Placebo; golimumabBiological

    SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg

  • golimumabBiological

    100 mg sc injections every 4 wks from wk 0 up to 5 yrs

Study groups in NCT00265096
Study groupRoleWhat they receive
002Experimentalgolimumab 50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
Receives: Biological: golimumab
001ExperimentalPlacebo; golimumab SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg
Receives: Biological: Placebo; golimumab
003Experimentalgolimumab 100 mg sc injections every 4 wks from wk 0 up to 5 yrs
Receives: Biological: golimumab

What is being measured

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

  1. American College of Rheumatology (ACR) 20 Response at Week 14

    ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])

    Measured: Baseline (Week 0), Week 4, Week 8 and Week 14

  2. Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24

    Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage.

    Measured: Baseline and Week 24

Secondary outcomes (4)

  1. Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline

    Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72. Zero (0) means no disease and 72 means maximal disease. PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14.

    Measured: Baseline, Week 4, Week 8 and Week 14

  2. Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24

    Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.

    Measured: Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24

  3. Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14

    The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.

    Measured: Baseline and Week 14

  4. American College of Rheumatology 20 at Week 24

    Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24.

    ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])

    Measured: Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24

Timeline

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

  1. First posted14 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionMay 2007
  4. Study completionJan 2012

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00265096
Sponsor's protocol ID
CR006340
Other IDs
C0524T08
Acronym
GO-REVEAL
Status last verified
Jul 2013
First submitted
12 Dec 2005
Last updated
19 Jul 2013
Data monitoring committee
Yes

Publications

  • Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309.

    PubMed 30412238

  • Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. doi: 10.3899/jrheum.160420. Epub 2016 Nov 1.

    PubMed 27803138

  • Aletaha D, Alasti F, Smolen JS. Disease activity states of the DAPSA, a psoriatic arthritis specific instrument, are valid against functional status and structural progression. Ann Rheum Dis. 2017 Feb;76(2):418-421. doi: 10.1136/annrheumdis-2016-209511. Epub 2016 Jul 25.

    PubMed 27457512

  • Kavanaugh A, van der Heijde D, Beutler A, Gladman D, Mease P, Krueger GG, McInnes IB, Helliwell P, Coates LC, Xu S. Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2016 Feb;68(2):267-74. doi: 10.1002/acr.22576.

    PubMed 25779603

  • Kavanaugh A, McInnes IB, Mease P, Krueger GG, Gladman D, van der Heijde D, Zhou Y, Lu J, Leu JH, Goldstein N, Beutler A. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study). Ann Rheum Dis. 2014 Sep;73(9):1689-94. doi: 10.1136/annrheumdis-2013-204902. Epub 2014 Apr 19.

    PubMed 24748630

  • Helliwell PS, Kavanaugh A. Comparison of composite measures of disease activity in psoriatic arthritis using data from an interventional study with golimumab. Arthritis Care Res (Hoboken). 2014 May;66(5):749-56. doi: 10.1002/acr.22204.

    PubMed 24127416

  • Kavanaugh A, McInnes IB, Krueger GG, Gladman D, Beutler A, Gathany T, Mack M, Tandon N, Han C, Mease P. Patient-reported outcomes and the association with clinical response in patients with active psoriatic arthritis treated with golimumab: findings through 2 years of a phase III, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1666-73. doi: 10.1002/acr.22044.

    PubMed 23666608

  • Kavanaugh A, van der Heijde D, McInnes IB, Mease P, Krueger GG, Gladman DD, Gomez-Reino J, Papp K, Baratelle A, Xu W, Mudivarthy S, Mack M, Rahman MU, Xu Z, Zrubek J, Beutler A. Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial. Arthritis Rheum. 2012 Aug;64(8):2504-17. doi: 10.1002/art.34436.

    PubMed 22378566

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing golimumab in people with Arthritis, Psoriatic, run by Centocor, Inc. at 51 sites in 6 countries.

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 6 inclusion and 3 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Canada, Poland, Belgium, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

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 16 Apr 2012). 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?

American College of Rheumatology (ACR) 20 Response at Week 14 (time frame: Baseline (Week 0), Week 4, Week 8 and Week 14). The study lists 2 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 NCT00265096, which also lists 8 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 19 Jul 2013.

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