Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

NCT01373151 | Completed Phase 2 Results DMC

• 2 other identifiers: IM133-0012010-023956-99
• Study Type: interventional
• Target: 418
• Locations: 19 countries
• Sites: 100

Brief Summary

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Achieving an American College of Rheumatology (ACR) 20% 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).

  At 12 Weeks

Secondary Outcomes (16)

• Percent of Participants With ACR 20 Response

  At 24 weeks

• Percent of Participants Achieving ACR 50 Response Rate

  At weeks 12 and 24

• Percent of Participants Achieving ACR 70 Response Rate

  At weeks 12 and 24

• Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)

  Baseline, weeks 12 and 24

• Percent of Participants With Remission by DAS28-CRP

  At weeks 12 and 24

Study Arms (7)

Arm 1

PLACEBO COMPARATOR

BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo

Drug: BMS-945429 Placebo; Biological: BMS-945429; Drug: Methotrexate; Drug: Adalimumab Placebo

Arm 2

EXPERIMENTAL

BMS-945429 + Methotrexate + Adalimumab Placebo

Biological: BMS-945429; Drug: Methotrexate; Drug: Adalimumab Placebo

Arm 3

EXPERIMENTAL

BMS-945429 + Methotrexate + Adalimumab Placebo

Biological: BMS-945429; Drug: Methotrexate; Drug: Adalimumab Placebo

Arm 4

EXPERIMENTAL

BMS-945429 + Methotrexate + Adalimumab Placebo

Biological: BMS-945429; Drug: Methotrexate; Drug: Adalimumab Placebo

Arm 5

EXPERIMENTAL

BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo

Biological: BMS-945429; Drug: Methotrexate Placebo; Drug: Methotrexate; Drug: Adalimumab Placebo

Arm 6

EXPERIMENTAL

BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo

Biological: BMS-945429; Drug: Methotrexate Placebo; Drug: Methotrexate; Drug: Adalimumab Placebo

Arm 7

ACTIVE COMPARATOR

Adalimumab + Methotrexate

Drug: Methotrexate; Drug: Adalimumab

Interventions

BMS-945429 Placebo DRUG

Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only

Arm 1

BMS-945429 BIOLOGICAL

Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only

Arm 4

Methotrexate DRUG

Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only

Arm 1

Methotrexate Placebo DRUG

Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only

Arm 5; Arm 6

Adalimumab Placebo DRUG

Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Adalimumab DRUG

Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks

Arm 7

Eligibility Criteria

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

You may qualify if:

• Inadequate response to Methotrexate
• Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
• American College of Rheumatology (ACR) global function status class 1-3
• Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
• High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

You may not qualify if:

• Previously received or currently receiving concomitant biologic therapy

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (100)

Sun Valley Arthritis Center, Ltd.

Peoria, Arizona, 85381, United States

Location

San Diego Arthritis Medical Clinic

San Diego, California, 92108, United States

Location

New England Research Associates, Llc

Trumbull, Connecticut, 06611, United States

Location

Quincy Medical Group

Quincy, Illinois, 62301, United States

Location

Rockford Orthopedic Associates, Llc.

Rockford, Illinois, 61107, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Arthritis Associates Of Mississippi

Jackson, Mississippi, 39202, United States

Location

Physician Research Collaboration, Llc

Lincoln, Nebraska, 68516, 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

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98104, United States

Location

Local Institution

Capital Federal, Buenos Aires, 1015, Argentina

Location

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Capital Federal, Buenos Aires, 1425, Argentina

Location

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Capital Federal, Buenos Aires, 1428, Argentina

Location

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Capital Federal, Buenos Aires, 1431, Argentina

Location

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Rosario, Santa Fe Province, 2000, Argentina

Location

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Córdoba, 5000, Argentina

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San Juan, 5400, Argentina

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Brussels, 1200, Belgium

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Hasselt, 3500, Belgium

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Goiânia, Goiás, 74110, Brazil

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Juiz de Fora, Minas Gerais, 36010, Brazil

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Curitiba, Paraná, 80060, Brazil

Location

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Curitiba, Paraná, 80440, Brazil

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Porto Alegre, Rio Grande do Sul, 91610, Brazil

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São Paulo, 04032, Brazil

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São Paulo, 04266, Brazil

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Montreal, Quebec, H2L 1S6, Canada

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Québec, Quebec, G1W 4R4, Canada

Location

Centre De Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

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Prague, 128 50, Czechia

Location

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Prague, 140 59, Czechia

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Bordeaux, 33076, France

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Chambray-lès-Tours, 37170, France

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Strasbourg, 67098, France

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Berlin, 14059, Germany

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Cologne, 50931, Germany

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Leipzig, 04103, Germany

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Würzburg, 97080, Germany

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Budapest, 1027, Hungary

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Debrecen, 4012, Hungary

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Gyula, 5700, Hungary

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Veszprém, 8200, Hungary

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Reggio Emilia, 42100, Italy

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Chiba, Chiba, 2608712, Japan

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Kitakyushu-shi, Fukuoka, 8078555, Japan

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Higashi-hiroshima-shi, Hiroshima, 7390002, Japan

Location

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Kato-shi, Hyōgo, 6731462, Japan

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Miyazaki, Miyazaki, 8800122, Japan

Location

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Nagano, Nagano, 3808582, Japan

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Nagasaki, Nagasaki, 8528501, Japan

Location

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Sasebo-shi, Nagasaki, 8571195, Japan

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Tomigusuku-shi, Okinawa, 9010243, Japan

Location

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Osaka, Osaka, 5458586, Japan

Location

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Shizuoka, Shizuoka, 4208623, Japan

Location

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Bunkyo-ku, Tokyo, 1138519, Japan

Location

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Shinjuku-Ku, Tokyo, 1608582, Japan

Location

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Toshima-ku, Tokyo, 1708476, Japan

Location

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Guadalajara, Jalisco, 42650, Mexico

Location

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Guadalajara, Jalisco, 45040, Mexico

Location

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Mexico City, Mexico City, 11850, Mexico

Location

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Morelia, Michioacan, 58270, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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Culiacán, Sinaloa, 80230, Mexico

Location

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San Luis Potosí City, 78213, Mexico

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Amsterdam, 1056 AB, Netherlands

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Katowice, 40-748, Poland

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Krakow, 31-531, Poland

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Poznan, 60773, Poland

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Warsaw, 01-868, Poland

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Warsaw, 02-118, Poland

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Kazan', 420064, Russia

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Moscow, 115522, Russia

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Novosibirsk, 630005, Russia

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Saint Petersburg, 191014, Russia

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Yaroslavl, 150003, Russia

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Yekaterinburg, 620102, Russia

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Pretoria, Gauteng, 0083, South Africa

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Pretoria, Gauteng, 0132, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Panorama, Western Cape, 7500, South Africa

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

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Tygerberg, Western Cape, 7505, South Africa

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Daegu, 705-718, South Korea

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Seoul, 133-792, South Korea

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Seoul, 137-701, South Korea

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A Coruña, 15006, Spain

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Madrid, 28040, Spain

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Santander, 39008, Spain

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Santiago de Compostela, 15706, Spain

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Seville, 41071, Spain

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Changhua, 500, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 404, Taiwan

Location

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Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P. The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study. Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249.

  PMID: 26138593 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

clazakizumab; Methotrexate; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: June 13, 2011
• First Posted: June 14, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: June 1, 2015
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-11

Locations

FR (3); AR (8); BE (2); ZA (6); CZ (2); BR (7); NL (1); RU (6); ES (5); JP (14); TW (4); IT (3); HU (4); CA (3); ME (7); PL (5); DE (4); KR (3); US (13)