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

Arthritis, Psoriatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490450
• Other study ID #: IM133-004
• Secondary ID: 2011-004016-29
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Est. completion date: June 2015

Study information

• Verified date: October 2021
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: June 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Biological:
• Placebo matching BMS-945429
Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
• BMS-945429
Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
• BMS-945429
Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
• BMS-945429
Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Locations

Country	Name	City	State
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Tucuman
Australia	Local Institution	Cairns	Queensland
Australia	Local Institution	Maroochydore	Queensland
Australia	Local Institution	Shenton Park	Western Australia
Australia	Local Institution	Woodville	South Australia
Canada	Local Institution	Montreal	Quebec
Canada	Centre De Rhumatologie De L Est Du Quebec	Rimouski	Quebec
Canada	Centre De Recherche Musculo-Squelettique	Trois-rivieres	Quebec
Canada	Manitoba Clinic	Winnipeg	Manitoba
Czechia	Local Institution	Pardubice
Czechia	Local Institution	Praha 2
Germany	Local Institution	Bad Nauheim
Germany	Local Institution	Erlangen
Germany	Local Institution	Planegg
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Hungary	Local Institution	Veszprem
Italy	Local Institution	Firenze
Italy	Local Institution	Napoli
Mexico	Local Institution	Mexico	Aguascalientes
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Zapopan	Jalisco
Poland	Local Institution	Bialystok
Poland	Local Institution	Dabrowka
Poland	Local Institution	Elblag
Poland	Local Institution	Poznan
Poland	Local Institution	Warszawa
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Yaroslavl
South Africa	Local Institution	Durban	KWA ZULU Natal
South Africa	Local Institution	Panorama, Cape Town	Western CAPE
South Africa	Local Institution	Pinelands, Cape Town	Western Cape
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Pretoria	Gauteng
Spain	Local Institution	A Coruna
Spain	Local Institution	Barcelona
Spain	Local Institution	Sevilla
United States	East Penn Rheumatology Associates, P.C.	Bethlehem	Pennsylvania
United States	Box Arthritis And Rheumatology Of The Carolinas, Pllc	Charlotte	North Carolina
United States	Denver Arthritis Clinic	Denver	Colorado
United States	Arthritis Associates Of Mississippi	Jackson	Mississippi
United States	Health Research Of Oklahoma	Oklahoma City	Oklahoma
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	Sarasota Arthritis Research Center	Sarasota	Florida
United States	New England Research Associates, Llc	Trumbull	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Czechia,  Germany,  Hungary,  Italy,  Mexico,  Poland,  Russian Federation,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate	To calculate the PASI score, the psoriasis plaques found on each body region are graded for their combined redness, thickness, and scaliness. The severity of the plaques in each region is graded on a 0 to 4 scale, with 0 meaning no involvement and 4 meaning severe involvement. Next, the amount of surface area on each body region that is covered by the plaques is calculated. The total surface area affected by psoriasis is graded from 0 to 6, with 0 meaning no involvement and 6 meaning greater than 90 percent of the region covered in plaques.; These grades are then fed into an equation to determine the patient's PASI score. The PASI score then is used as a clinical assessment of the patient's psoriasis involvement. A person free of psoriasis has a score of 0 and the score could be as high as 72.; PASI 75 means that the person's PASI score dropped by 75 percent as a result of the psoriasis treatment.	Week 16 and Week 24
Secondary	Percent of Participants Achieving ACR50 and ACR70 Response Rate	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).	Week 16 and Week 24
Secondary	Percent of Participants Achieving ACR20 Response Rate at Week 24	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).	Week 24
Secondary	Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response	For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). There are 20 questions in eight categories of functioning - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The highest component score in each category determines the score for the category, unless aids or devices are required. Dependence on equipment or physical assistance increases a lower score to the level of 2 to more accurately represent underlying disability. The eight category scores are averaged into an overall HAQ score on a scale from zero (no disability) to three (completely disabled). The scale is not truly continuous but has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3).; Response is measured by a reduction of at least 0.3 unit from baseline in HAQ index.	Weeks 16 and Week 24
Secondary	Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores	The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.	Baseline and Week 16
Secondary	Mean Change From Baseline at Week 24 in SF-36 Scores	The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.	Baseline and Week 24
Secondary	Number of Participants With Anti-clazakizumab Antibodies		Up to 24 weeks

External Links

•   BMS clinical trial educational resource