A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis

NCT ID: NCT01009086

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 615 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-05-31

Brief Summary

The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.

Detailed Description

This is a randomized (participants are assigned different treatments based on chance), double-blind (neither the participant nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group (each group of participants will be treated at the same time), and multicenter (study conducted at multiple sites) study. Approximately, 615 participants will participate in this study. Participants will be assigned to one of three treatment groups: Group I: ustekinumab 45 mg, Group II: ustekinumab 90 mg, and Group III: placebo group (an inactive substance). Participants will receive either 45 mg ustekinumab or 90 mg ustekinumab at Weeks 0, 4, and every 12 weeks until Week 88 as randomized to respective groups. Participants in placebo group will receive placebo at Weeks 0, 4, 16, and 20 and 45 mg ustekinumab at Weeks 24 and 28 followed by every 12 weeks dosing until Week 88. Participants who do not have greater than or equal to 5 percentage improvement in their disease (tender and swollen joints) will be eligible for an early escape. Specifically, during early escape at Week 16, participants in Group I will receive 90 mg ustekinumab, for participants in Group II same dosing schedule will be continued, and participants in placebo group will receive 45 mg ustekinumab. Safety evaluations will include assessments of adverse events, clinical laboratory tests, and physical examination. The maximum study duration will be approximately 108 weeks.

Conditions

Arthritis, Psoriatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants will receive subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants will cross over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 45 mg ustekinumab will be given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a SC placebo injection will be given at Week 24 to maintain the blind.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

SC injections

Ustekinumab 45 mg

Participants will receive SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 90 mg ustekinumab will be given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

SC injections

Ustekinumab 45 mg

Intervention Type: DRUG

SC injections

Ustekinumab 90 mg

Intervention Type: DRUG

SC injections

Ustekinumab 90 mg

Participants will receive SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, the same dosage schedule will continue. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

SC injections

Ustekinumab 90 mg

Intervention Type: DRUG

SC injections

Interventions

Placebo

SC injections

Intervention Type: DRUG

Ustekinumab 45 mg

SC injections

Intervention Type: DRUG

Ustekinumab 90 mg

SC injections

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have had a documented diagnosis of psoriatic arthritis (PsA) at least 6 months
• Have a diagnosis of active PsA at the time of entry into the study
• If the participant is using methotrexate they should have started treatment at a dose not to exceed 25 milligram per week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate. Methotrexate route of administration and doses should be stable for at least 4 weeks prior to the first administration of study agent. If currently not using methotrexate, must have not received methotrexate for at least 4 weeks prior to the first administration of the study agent

Exclusion Criteria

• Have other inflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
• Have used any therapeutic agent targeted at reducing interleukin (IL)-12 or IL-23, including but not limited to ustekinumab and briakinumab (ABT-874)
• Have used any biologic agents that are targeted for reducing tumor necrosis factor-alpha, including but not limited to infliximab, etanercept, adalimumab, and golimumab
• Have a medical history of latent or active granulomatous infection
• Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years of the beginning of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Encinitas, California, United States

La Jolla, California, United States

San Diego, California, United States

Denver, Colorado, United States

Trumbull, Connecticut, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Wheaton, Maryland, United States

Boston, Massachusetts, United States

Fall River, Massachusetts, United States

Worcester, Massachusetts, United States

Edina, Minnesota, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Freehold, New Jersey, United States

Norman, Oklahoma, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Duncansville, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Jackson, Tennessee, United States

Houston, Texas, United States

Webster, Texas, United States

Seattle, Washington, United States

Camperdown, , Australia

Heidelberg, , Australia

Maroochydore, , Australia

Melbourne, , Australia

Perth, , Australia

Woodville, , Australia

Graz, , Austria

Innsbruck, , Austria

Vienna, , Austria

Edmonton, Alberta, Canada

Kelowna, British Columbia, Canada

Vancouver, British Columbia, Canada

Moncton, New Brunswick, Canada

St. John's, Newfoundland and Labrador, Canada

Halifax, Nova Scotia, Canada

Barrie, Ontario, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

North Bay, Ontario, Canada

Saint Catherines, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Waterloo, Ontario, Canada

Windsor, Ontario, Canada

Québec, Quebec, Canada

Trois-Rivières, Quebec, Canada

Westmount, Quebec, Canada

Helsinki, , Finland

Hyvinkää, , Finland

Berlin, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Herne, , Germany

Kiel, , Germany

Mahlow, , Germany

Mainz, , Germany

Regensburg, , Germany

Tübingen, , Germany

Budapest, , Hungary

Debrecen, , Hungary

Kecskemét, , Hungary

Szeged, , Hungary

Szolnok, , Hungary

Veszprém, , Hungary

Riga, , Latvia

Alytus, , Lithuania

Kaunas, , Lithuania

Klaipėda, , Lithuania

Šiauliai, , Lithuania

Auckland, , New Zealand

Christchurch, , New Zealand

Rotorua, , New Zealand

Wellington, , New Zealand

Bialystok, , Poland

Bydgoszcz, , Poland

Elblag, , Poland

Lublin, , Poland

Torun, , Poland

Warsaw, , Poland

Korolyov, , Russia

Moscow, , Russia

Novosibirsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Yekaterinburg, , Russia

Barcelona, , Spain

Oviedo, , Spain

Santiago de Compostela, , Spain

Seville, , Spain

Cannock, , United Kingdom

Glasgow, , United Kingdom

London, , United Kingdom

Metropolitan Borough of Wirral, , United Kingdom

Salford, , United Kingdom

Wigan, , United Kingdom

Countries

United States; Australia; Austria; Canada; Finland; Germany; Hungary; Latvia; Lithuania; New Zealand; Poland; Russia; Spain; United Kingdom

References

Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Ustekinumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1413-1423. doi: 10.1007/s40744-024-00705-x. Epub 2024 Aug 9.

Reference Type: DERIVED

PMID: 39120848 (View on PubMed)

Helliwell PS, Gladman DD, Chakravarty SD, Kafka S, Karyekar CS, You Y, Campbell K, Sweet K, Kavanaugh A, Gensler LS. Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naive active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials. RMD Open. 2020 Feb;6(1):e001149. doi: 10.1136/rmdopen-2019-001149.

Reference Type: DERIVED

PMID: 32209721 (View on PubMed)

Siebert S, Sweet K, Dasgupta B, Campbell K, McInnes IB, Loza MJ. Responsiveness of Serum C-Reactive Protein, Interleukin-17A, and Interleukin-17F Levels to Ustekinumab in Psoriatic Arthritis: Lessons From Two Phase III, Multicenter, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2019 Oct;71(10):1660-1669. doi: 10.1002/art.40921. Epub 2019 Sep 3.

Reference Type: DERIVED

PMID: 31070869 (View on PubMed)

Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.

Reference Type: DERIVED

PMID: 30739254 (View on PubMed)

Rahman P, Puig L, Gottlieb AB, Kavanaugh A, McInnes IB, Ritchlin C, Li S, Wang Y, Song M, Mendelsohn A, Han C; PSUMMIT 1 and 2 Study Groups. Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1812-1822. doi: 10.1002/acr.23000. Epub 2016 Oct 21.

Reference Type: DERIVED

PMID: 27483458 (View on PubMed)

Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016 Nov;75(11):1984-1988. doi: 10.1136/annrheumdis-2015-209068. Epub 2016 Apr 20.

Reference Type: DERIVED

PMID: 27098404 (View on PubMed)

Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, Li S, Wang Y, Mendelsohn AM, Song M, Zhu Y, Rahman P, McInnes IB; PSUMMIT 1 Study Group. Maintenance of Clinical Efficacy and Radiographic Benefit Through Two Years of Ustekinumab Therapy in Patients With Active Psoriatic Arthritis: Results From a Randomized, Placebo-Controlled Phase III Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1739-49. doi: 10.1002/acr.22645.

Reference Type: DERIVED

PMID: 26097039 (View on PubMed)

McInnes IB, Kavanaugh A, Gottlieb AB, Puig L, Rahman P, Ritchlin C, Brodmerkel C, Li S, Wang Y, Mendelsohn AM, Doyle MK; PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013 Aug 31;382(9894):780-9. doi: 10.1016/S0140-6736(13)60594-2. Epub 2013 Jun 13.

Reference Type: DERIVED

PMID: 23769296 (View on PubMed)

Other Identifiers

CNTO1275PSA3001

Identifier Type: OTHER

Identifier Source: secondary_id

2009-012264-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016315

Identifier Type: -

Identifier Source: org_study_id

NCT01902706

Identifier Type: -

Identifier Source: nct_alias