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

NCT00265096 | Completed Phase 3 Results DMC

• 2 other identifiers: CR006340C0524T08
• Study Type: interventional
• Target: 407
• Locations: 6 countries
• Sites: 51

Brief 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). 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.

Conditions

Arthritis, Psoriatic

Keywords

Psoriatic Arthritis; Spondyloarthritis; Spondyloarthropathy; subcutaneous injection

Outcome Measures

Primary Outcomes (2)

• 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 \[CRP\])

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

• 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.

  Baseline and Week 24

Secondary Outcomes (4)

• 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

  Baseline, Week 4, Week 8 and Week 14

• Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24

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

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

  Baseline and Week 14

• American College of Rheumatology 20 at Week 24

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

Study Arms (3)

002

EXPERIMENTAL

golimumab 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

Biological: golimumab

001

EXPERIMENTAL

Placebo; 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

Biological: Placebo; golimumab

003

EXPERIMENTAL

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

Biological: golimumab

Interventions

golimumab BIOLOGICAL

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

002

Placebo; golimumab BIOLOGICAL

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

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centocor, Inc.: lead
• Schering-Plough: collaborator

Study Sites (51)

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Huntsville, Alabama, United States

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La Jolla, California, United States

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Upland, California, United States

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Aventura, Florida, United States

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Coeur d'Alene, Idaho, United States

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Kansas City, Kansas, United States

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Wheaton, Maryland, United States

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Worcester, Massachusetts, United States

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Omaha, Nebraska, United States

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Cincinnati, Ohio, United States

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Mayfield, Ohio, United States

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Lake Oswego, Oregon, United States

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Portland, Oregon, United States

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Duncansville, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Houston, Texas, United States

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Edmonds, Washington, United States

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Seattle, Washington, United States

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Merksem, Belgium

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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North Bay, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sante Foy, Quebec, Canada

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Claire, Canada

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Hamilton Ontario, Canada

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Newmarket, Canada

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Saskatoon, Canada

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Vancouver, Canada

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Bialystok, Poland

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Elblag, Poland

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Kalisz, Poland

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Poznan, Poland

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Szczecin, Poland

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Torun, Poland

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Warsaw, Poland

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Santiago de Compostela, Spain

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Valencia, Spain

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Glasgow, United Kingdom

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London, United Kingdom

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Middlesbrough, United Kingdom

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Wigan, United Kingdom

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Related Publications (8)

• 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.

  PMID: 30412238 DERIVED

• 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.

  PMID: 27803138 DERIVED

• 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.

  PMID: 27457512 DERIVED

• 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.

  PMID: 25779603 DERIVED

• 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.

  PMID: 24748630 DERIVED

• 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.

  PMID: 24127416 DERIVED

• 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.

  PMID: 23666608 DERIVED

• 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.

  PMID: 22378566 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic; Spondylarthritis; Spondylarthropathies

Interventions

golimumab

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Centocor Research and Development, Inc.

1-800-457-6399

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 14, 2005
• Study Start: December 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: January 1, 2012
• Last Updated: July 19, 2013
• Results First Posted: April 16, 2012

Record last verified: 2013-07

Locations

BE (5); ES (2); GB (4); US (18); CA (15); PL (7)