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Rheumatoid ArthritisPhase 2NCT02015520

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

A Phase 2 study testing Clazakizumab in people with Rheumatoid Arthritis, run by CSL Behring at 55 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Clazakizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
143 participants
Where
55 sitesin 9 countries
Study dates
Jun 2012to Jun 2015
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

55 sites in 9 countries.

55 sites in 9 countries

United States21 sites

  • Albuquerque Center For Rheumatology

    Albuquerque, New Mexico, 87102

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Low Country Rheumatology

    Charleston, South Carolina, 29406

  • Joint And Muscle Medical Care And Research Institute (Jmmcri)

    Charlotte, North Carolina, 28204

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio, 45219

  • St. Paul Rheumatology, P.A.

    Eagan, Minnesota, 55121

  • Physicians East, Pa

    Greenville, North Carolina, 27834

  • Mercy Clinic Hot Springs Communities

    Hot Springs, Arkansas, 71913

  • Rheumatology Associates Of North Alabama, P.C.

    Huntsville, Alabama, 35801

  • Rheumatology Consultants Pllc

    Knoxville, Tennessee, 37909

  • Physician Research Collaboration, Llc

    Lincoln, Nebraska, 68516

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

    Long Beach, California, 90806

  • Paramount Medical Research & Consulting, Llc

    Middleburg Heights, Ohio, 44130

  • Center For Inflammatory Disease

    Nashville, Tennessee, 37203

  • Arthritis & Rheumatology Center Of Oklahoma Pllc

    Oklahoma City, Oklahoma, 73103

  • Health Research Of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Sarasota Arthritis Research Center

    Sarasota, Florida, 34239

  • Seattle Rheumatology Associates

    Seattle, Washington, 98122

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

Other trials in United States

Japan8 sites

  • Local Institution

    Chiba, Chiba, 2608712

  • Local Institution

    Kato-shi, Hyōgo, 6731462

  • Local Institution

    Kitakyushu-shi, Fukuoka, 8078555

  • Local Institution

    Nagano, Nagano, 3808582

  • Local Institution

    Nishimura, Wakayama, 6492211

  • Local Institution

    Sasebo-shi, Nagasaki, 8571195

  • Local Institution

    Shinjuku-Ku, Tokyo, 1608582

  • Local Institution

    Toshima-ku, Tokyo, 1708476

Other trials in Japan

Mexico6 sites

  • Local Institution

    Guadalajara

  • Local Institution

    León, Guanajuato, 37000

  • Local Institution

    Mérida, Yucatán, 97000

  • Local Institution

    Mérida, Yucatán, 97070

  • Local Institution

    San Luis Potosí City, 78200

  • Local Institution

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

Argentina5 sites

  • Local Institution

    Buenos Aires, 1121

  • Local Institution

    Buenos Aires, 1426

  • Local Institution

    Córdoba, 5000

  • Local Institution

    Quilmes, Buenos Aires, 1878

  • Local Institution

    San Miguel de Tucumán, 4000

Other trials in Argentina

Italy4 sites

  • Local Institution

    Catanzaro, 88100

  • Local Institution

    Florence, 50139

  • Local Institution

    Naples, 80131

  • Local Institution

    Pisa, 56126

Other trials in Italy

Canada3 sites

  • Cividino Medicine Professional Corporation

    Hamilton, Ontario, L8N 2B6

  • Credit Valley Rheumatology

    Mississauga, Ontario, L5M 2V8

  • Dr. Latha Naik Medical Professional Corporation

    Saskatoon, Saskatchewan, S7K 3H3

Other trials in Canada

France3 sites

  • Local Institution

    Bordeaux, 33076

  • Local Institution

    Paris, 75679

  • Local Institution

    Poitiers, 86021

Other trials in France

Hungary3 sites

  • Local Institution

    Budapest, 1023

  • Local Institution

    Debrecen, 4012

  • Local Institution

    Veszprém, 8200

Other trials in Hungary

South Africa2 sites

  • Local Institution

    Cape Town, Western Cape, 7500

  • Local Institution

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

About this study

Official title: A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors

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

Being tested
Clazakizumab, Placebo (Matching with Clazakizumab)
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClazakizumabDrug

    Also called BMS-945429

  • Placebo (Matching with Clazakizumab)Drug

Study groups in NCT02015520
Study groupRoleWhat they receive
Arm 1: Clazakizumab (Dose # A) (Double-Blind)ExperimentalClazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate
Receives: Drug: Clazakizumab
Arm 2: Clazakizumab (Dose # B) (Double-Blind)ExperimentalClazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate
Receives: Drug: Clazakizumab
Arm 3: Clazakizumab (Dose # C) (Double-Blind)ExperimentalClazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate
Receives: Drug: Clazakizumab
Arm 4: Placebo matching with Clazakizumab (Double-Blind)ExperimentalClazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate
Receives: Drug: Placebo (Matching with Clazakizumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and Week 12

Secondary outcomes (7)

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

    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).

    Measured: At week 12

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

    CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.

    CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity

    Measured: Baseline and week 12

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

    SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.

    0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity

    Measured: Baseline and week 12

  4. Boolean Remission at Week 12

    Boolean-based definition:

    At any time point, a patient must satisfy all of the following:

    TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)

    Measured: At week 12

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

    Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.

    Measured: Baseline and Week 12

  6. Percent of Participants With a DAS28-Erythrocyte Sedimentation Rate (ESR) <2.6

    DAS28- ESR = Disease Activity Scores 28 based on erythrocyte sedimentation rate. A DAS28-ESR below 2.6 is interpreted as remission.

    Measured: At week 12

  7. Percent of Participants With a DAS28-C Reactive Protein (CRP) <2.6

    DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.

    Measured: At week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2013
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02015520
Sponsor's protocol ID
IM133-066
Other IDs
2013-003780-65
Status last verified
Apr 2021
First submitted
6 Dec 2013
Last updated
12 May 2021
Data monitoring committee
No

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