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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection in Adults With Active Psoriatic Arthritis

NCT01490450•CSL Behring

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (49)

San Diego Arthritis Medical Clinic

San Diego, California, United States

Denver Arthritis Clinic

Denver, Colorado, United States

New England Research Associates, Llc

Trumbull, Connecticut, United States

Sarasota Arthritis Research Center

Sarasota, Florida, United States

Arthritis Associates Of Mississippi

Jackson, Mississippi, United States

Box Arthritis And Rheumatology Of The Carolinas, Pllc

Charlotte, North Carolina, United States

Health Research Of Oklahoma

Oklahoma City, Oklahoma, United States

East Penn Rheumatology Associates, P.C.

Bethlehem, Pennsylvania, United States

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Key Dates

Start Date

December 1, 2011

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2015

Last Updated

November 5, 2021

Enrollment

165

ACTUAL participants

Conditions

Arthritis, Psoriatic

Interventions

Placebo matching BMS-945429

BIOLOGICAL

BMS-945429

BIOLOGICAL

BMS-945429

BIOLOGICAL

BMS-945429

BIOLOGICAL

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis

NCT06522035

Arthritis, Psoriatic

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NOT_YET_RECRUITING

Pain in Inflammatory Joint Diseases

NCT06718569

ArthritisArthritis, Juvenile Idiopathic+4 more

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis

Pain in Inflammatory Joint Diseases

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Psoriatic Arthritis Pathobiology and Its Relationship With Clinical Disease Activity

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis