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Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy

NCT ID: NCT01490450

Last Updated: 2021-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).

Detailed Description

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Conditions

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Arthritis, Psoriatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PBO: Placebo matching BMS-945429

Group Type PLACEBO_COMPARATOR

Placebo matching BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

BMS-945429 (25mg)

Group Type EXPERIMENTAL

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

BMS-945429 (100mg)

Group Type EXPERIMENTAL

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

BMS-945429 (200mg)

Group Type EXPERIMENTAL

BMS-945429

Intervention Type BIOLOGICAL

Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Interventions

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Placebo matching BMS-945429

Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Intervention Type BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
* Inadequate response to NSAID and/or non-biologic DMARD
* Minimum of 3 swollen and 3 tender joints
* Active psoriatic skin lesions over minimum 3% body surface area
* high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL

Exclusion Criteria

* Previously received or currently receiving concomitant biologic therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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San Diego Arthritis Medical Clinic

San Diego, California, United States

Site Status

Denver Arthritis Clinic

Denver, Colorado, United States

Site Status

New England Research Associates, Llc

Trumbull, Connecticut, United States

Site Status

Sarasota Arthritis Research Center

Sarasota, Florida, United States

Site Status

Arthritis Associates Of Mississippi

Jackson, Mississippi, United States

Site Status

Box Arthritis And Rheumatology Of The Carolinas, Pllc

Charlotte, North Carolina, United States

Site Status

Health Research Of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

East Penn Rheumatology Associates, P.C.

Bethlehem, Pennsylvania, United States

Site Status

Local Institution

Capital Federal, Buenos Aires, Argentina

Site Status

Local Institution

Capital Federal, Buenos Aires, Argentina

Site Status

Local Institution

Capital Federal, Buenos Aires, Argentina

Site Status

Local Institution

San Miguel de Tucumán, , Argentina

Site Status

Local Institution

Cairns, Queensland, Australia

Site Status

Local Institution

Maroochydore, Queensland, Australia

Site Status

Local Institution

Woodville, South Australia, Australia

Site Status

Local Institution

Shenton Park, Western Australia, Australia

Site Status

Manitoba Clinic

Winnipeg, Manitoba, Canada

Site Status

Local Institution

Montreal, Quebec, Canada

Site Status

Centre De Rhumatologie De L Est Du Quebec

Rimouski, Quebec, Canada

Site Status

Centre De Recherche Musculo-Squelettique

Trois-Rivières, Quebec, Canada

Site Status

Local Institution

Pardubice, , Czechia

Site Status

Local Institution

Prague, , Czechia

Site Status

Local Institution

Bad Nauheim, , Germany

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Local Institution

Erlangen, , Germany

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Local Institution

Planegg, , Germany

Site Status

Local Institution

Budapest, , Hungary

Site Status

Local Institution

Budapest, , Hungary

Site Status

Local Institution

Debrecen, , Hungary

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Veszprém, , Hungary

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Florence, , Italy

Site Status

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Napoli, , Italy

Site Status

Local Institution

México, Aguascalientes, Mexico

Site Status

Local Institution

Zapopan, Jalisco, Mexico

Site Status

Local Institution

Monterrey, Nuevo León, Mexico

Site Status

Local Institution

Bialystok, , Poland

Site Status

Local Institution

Dąbrówka, , Poland

Site Status

Local Institution

Elblag, , Poland

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Poznan, , Poland

Site Status

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Warsaw, , Poland

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Local Institution

Moscow, , Russia

Site Status

Local Institution

Yaroslavl, , Russia

Site Status

Local Institution

Pretoria, Gauteng, South Africa

Site Status

Local Institution

Pretoria, Gauteng, South Africa

Site Status

Local Institution

Durban, KwaZulu-Natal, South Africa

Site Status

Local Institution

Panorama, Cape Town, Western Cape, South Africa

Site Status

Local Institution

Pinelands, Cape Town, Western Cape, South Africa

Site Status

Local Institution

A Coruña, , Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Seville, , Spain

Site Status

Countries

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France United States Argentina Australia Canada Czechia Germany Hungary Italy Mexico Poland Russia South Africa Spain

References

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Mease PJ, Gottlieb AB, Berman A, Drescher E, Xing J, Wong R, Banerjee S. The Efficacy and Safety of Clazakizumab, an Anti-Interleukin-6 Monoclonal Antibody, in a Phase IIb Study of Adults With Active Psoriatic Arthritis. Arthritis Rheumatol. 2016 Sep;68(9):2163-73. doi: 10.1002/art.39700.

Reference Type DERIVED
PMID: 27059799 (View on PubMed)

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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2011-004016-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM133-004

Identifier Type: -

Identifier Source: org_study_id