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

NCT01490450 | Completed Phase 2 Results DMC

• 2 other identifiers: IM133-0042011-004016-29
• Study Type: interventional
• Target: 165
• Locations: 13 countries
• Sites: 49

Brief Summary

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).

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)

  The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).

  At 16 weeks

Secondary Outcomes (7)

• Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate

  Week 16 and Week 24

• Percent of Participants Achieving ACR50 and ACR70 Response Rate

  Week 16 and Week 24

• Percent of Participants Achieving ACR20 Response Rate at Week 24

  Week 24

• Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response

  Weeks 16 and Week 24

• Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores

  Baseline and Week 16

Study Arms (4)

PBO: Placebo matching BMS-945429

PLACEBO COMPARATOR

Biological: Placebo matching BMS-945429

BMS-945429 (25mg)

EXPERIMENTAL

Biological: BMS-945429

BMS-945429 (100mg)

EXPERIMENTAL

Biological: BMS-945429

BMS-945429 (200mg)

EXPERIMENTAL

Biological: BMS-945429

Interventions

Placebo matching BMS-945429 BIOLOGICAL

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

PBO: Placebo matching BMS-945429

BMS-945429 BIOLOGICAL

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

BMS-945429 (25mg)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Previously received or currently receiving concomitant biologic therapy

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (49)

San Diego Arthritis Medical Clinic

San Diego, California, 92108, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230, United States

Location

New England Research Associates, Llc

Trumbull, Connecticut, 06611, United States

Location

Sarasota Arthritis Research Center

Sarasota, Florida, 34239, United States

Location

Arthritis Associates Of Mississippi

Jackson, Mississippi, 39202, United States

Location

Box Arthritis And Rheumatology Of The Carolinas, Pllc

Charlotte, North Carolina, 28210, United States

Location

Health Research Of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

East Penn Rheumatology Associates, P.C.

Bethlehem, Pennsylvania, 18015, United States

Location

Local Institution

Capital Federal, Buenos Aires, 1015, Argentina

Location

Local Institution

Capital Federal, Buenos Aires, 1425, Argentina

Location

Local Institution

Capital Federal, Buenos Aires, 1428, Argentina

Location

Local Institution

San Miguel de Tucumán, 4000, Argentina

Location

Local Institution

Cairns, Queensland, 4870, Australia

Location

Local Institution

Maroochydore, Queensland, 4558, Australia

Location

Local Institution

Woodville, South Australia, 5011, Australia

Location

Local Institution

Shenton Park, Western Australia, 6008, Australia

Location

Manitoba Clinic

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Local Institution

Montreal, Quebec, H2L 1S6, Canada

Location

Centre De Rhumatologie De L Est Du Quebec

Rimouski, Quebec, G5L 8W1, Canada

Location

Centre De Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Local Institution

Pardubice, 530 02, Czechia

Location

Local Institution

Prague, 128 50, Czechia

Location

Local Institution

Bad Nauheim, 61231, Germany

Location

Local Institution

Erlangen, 91054, Germany

Location

Local Institution

Planegg, 82152, Germany

Location

Local Institution

Budapest, 1023, Hungary

Location

Local Institution

Budapest, 1062, Hungary

Location

Local Institution

Debrecen, 4012, Hungary

Location

Local Institution

Veszprém, 8200, Hungary

Location

Local Institution

Florence, 50139, Italy

Location

Local Institution

Napoli, 80131, Italy

Location

Local Institution

México, Aguascalientes, 20127, Mexico

Location

Local Institution

Zapopan, Jalisco, 45190, Mexico

Location

Local Institution

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution

Bialystok, 15-351, Poland

Location

Local Institution

Dąbrówka, 62-069, Poland

Location

Local Institution

Elblag, 82-300, Poland

Location

Local Institution

Poznan, 60773, Poland

Location

Local Institution

Warsaw, 01-868, Poland

Location

Local Institution

Moscow, 115522, Russia

Location

Local Institution

Yaroslavl, 150003, Russia

Location

Local Institution

Pretoria, Gauteng, 0083, South Africa

Location

Local Institution

Pretoria, Gauteng, 0084, South Africa

Location

Local Institution

Durban, KwaZulu-Natal, 4001, South Africa

Location

Local Institution

Panorama, Cape Town, Western Cape, 7500, South Africa

Location

Local Institution

Pinelands, Cape Town, Western Cape, 7405, South Africa

Location

Local Institution

A Coruña, 15006, Spain

Location

Local Institution

Barcelona, 08036, Spain

Location

Local Institution

Seville, 41071, Spain

Location

Related Publications (1)

• 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.

  PMID: 27059799 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

clazakizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: CSL Behring

clinicaltrials@cslbehring.com

610-878-4000

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 14, 2011
• First Posted: December 13, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2015
• Last Updated: November 5, 2021
• Results First Posted: November 5, 2021

Record last verified: 2021-10

Locations

HU (4); RU (2); PL (5); AR (4); CA (4); IT (2); US (8); ZA (5); ES (3); DE (3); AU (4); CZ (2); ME (3)