Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

NCT02015520 | Completed Phase 2 Results

• 2 other identifiers: IM133-0662013-003780-65
• Study Type: interventional
• Target: 143
• Locations: 9 countries
• Sites: 55

Brief Summary

The primary purpose of this study is to identify an appropriate dose of study medication.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12

  DAS28-CRP describes severity of rheumatoid arthritis. The components of the joint count assessment are shoulder, elbow, wrist, metacarpophalangeal joints 1 through 5, proximal interphalangeal joints 1 through 5, and the knee joints on the right and left sides, whereby the number of affected joints, tender and swollen, respectively, are counted. The formula used to calculate the score is: DAS28-CRP=0.56 \\times \\sqrt{TEN28} + 0.28 \\times \\sqrt{SW28} + 0.36 \\times \\ln(CRP+1) + 0.014 \\times SA+0.96 with: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale between 0 and 100 ("0":no activity, "100": highest activity possible). DAS-CRP score range is 0.49 to 9.07 A DAS-CRP value \>5.1 corresponds to a high disease activity A DAS-28 reduction by 0.6 represents a moderate improvement. A reduction \>1.2 represents a major improvement

  Baseline and Week 12

Secondary Outcomes (7)

• American College of Rheumatology (ACR) 20/50/70 Response Rates

  At week 12

• Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12

  Baseline and week 12

• Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12

  Baseline and week 12

• Boolean Remission at Week 12

  At week 12

• Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12

  Baseline and Week 12

Study Arms (4)

Arm 1: Clazakizumab (Dose # A) (Double-Blind)

EXPERIMENTAL

Clazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate

Drug: Clazakizumab

Arm 2: Clazakizumab (Dose # B) (Double-Blind)

EXPERIMENTAL

Clazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate

Drug: Clazakizumab

Arm 3: Clazakizumab (Dose # C) (Double-Blind)

EXPERIMENTAL

Clazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate

Drug: Clazakizumab

Arm 4: Placebo matching with Clazakizumab (Double-Blind)

EXPERIMENTAL

Clazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate

Drug: Placebo (Matching with Clazakizumab)

Interventions

Clazakizumab DRUG

Also known as: BMS-945429

Arm 1: Clazakizumab (Dose # A) (Double-Blind); Arm 2: Clazakizumab (Dose # B) (Double-Blind); Arm 3: Clazakizumab (Dose # C) (Double-Blind)

Placebo (Matching with Clazakizumab) DRUG

Arm 4: Placebo matching with Clazakizumab (Double-Blind)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American Rheumatism association (ARA) \[1987\] or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) \[2010\]) at least 16 weeks prior to screening
• ACR global functional status class of 1 to 3
• Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
• All subjects must have been receiving treatment with a minimum dose of 15 mg per week of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is permitted, if it is at a dose approved for the treatment of RA and the dose has been stable for at least 28 days prior to screening
• Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
• Elevated High-sensitivity (hs) CRP and/or ESR

You may not qualify if:

• Active serious infection
• History of or active tuberculosis (TB)
• Elevated liver function tests (LFTs)

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (55)

Rheumatology Associates Of North Alabama, P.C.

Huntsville, Alabama, 35801, United States

Location

Mercy Clinic Hot Springs Communities

Hot Springs, Arkansas, 71913, United States

Location

Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

Long Beach, California, 90806, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Sarasota Arthritis Research Center

Sarasota, Florida, 34239, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

St. Paul Rheumatology, P.A.

Eagan, Minnesota, 55121, United States

Location

Physician Research Collaboration, Llc

Lincoln, Nebraska, 68516, United States

Location

Albuquerque Center For Rheumatology

Albuquerque, New Mexico, 87102, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Joint And Muscle Medical Care And Research Institute (Jmmcri)

Charlotte, North Carolina, 28204, United States

Location

Physicians East, Pa

Greenville, North Carolina, 27834, United States

Location

Cincinnati Rheumatic Disease Study Group

Cincinnati, Ohio, 45219, United States

Location

Paramount Medical Research & Consulting, Llc

Middleburg Heights, Ohio, 44130, United States

Location

Arthritis & Rheumatology Center Of Oklahoma Pllc

Oklahoma City, Oklahoma, 73103, United States

Location

Health Research Of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Healthcare Research Consultants

Tulsa, Oklahoma, 74135, United States

Location

Low Country Rheumatology

Charleston, South Carolina, 29406, United States

Location

Rheumatology Consultants Pllc

Knoxville, Tennessee, 37909, United States

Location

Center For Inflammatory Disease

Nashville, Tennessee, 37203, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98122, United States

Location

Local Institution

Quilmes, Buenos Aires, 1878, Argentina

Location

Local Institution

Buenos Aires, 1121, Argentina

Location

Local Institution

Buenos Aires, 1426, Argentina

Location

Local Institution

Córdoba, 5000, Argentina

Location

Local Institution

San Miguel de Tucumán, 4000, Argentina

Location

Cividino Medicine Professional Corporation

Hamilton, Ontario, L8N 2B6, Canada

Location

Credit Valley Rheumatology

Mississauga, Ontario, L5M 2V8, Canada

Location

Dr. Latha Naik Medical Professional Corporation

Saskatoon, Saskatchewan, S7K 3H3, Canada

Location

Local Institution

Bordeaux, 33076, France

Location

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Paris, 75679, France

Location

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Poitiers, 86021, France

Location

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Budapest, 1023, Hungary

Location

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Debrecen, 4012, Hungary

Location

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Veszprém, 8200, Hungary

Location

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Catanzaro, 88100, Italy

Location

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Florence, 50139, Italy

Location

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Napoli, 80131, Italy

Location

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Pisa, 56126, Italy

Location

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Chiba, Chiba, 2608712, Japan

Location

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Kitakyushu-shi, Fukuoka, 8078555, Japan

Location

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Kato-shi, Hyōgo, 6731462, Japan

Location

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Nagano, Nagano, 3808582, Japan

Location

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Sasebo-shi, Nagasaki, 8571195, 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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Nishimura, Wakayama, 6492211, Japan

Location

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Tijuana, Estado de Baja California, 22010, Mexico

Location

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León, Guanajuato, 37000, Mexico

Location

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Mérida, Yucatán, 97000, Mexico

Location

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Mérida, Yucatán, 97070, Mexico

Location

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Guadalajara, Mexico

Location

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San Luis Potosí City, 78200, Mexico

Location

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Cape Town, Western Cape, 7500, South Africa

Location

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Stellenbosch, Western Cape, 7600, South Africa

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

clazakizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System 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: December 6, 2013
• First Posted: December 19, 2013
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2015
• Last Updated: May 12, 2021
• Results First Posted: April 19, 2021

Record last verified: 2021-04

Locations

CA (3); ZA (2); IT (4); ME (6); HU (3); US (21); JP (8); AR (5); FR (3)