Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis (RA)

September 23, 2015 updated by: Bristol-Myers Squibb

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

The purpose of this study is to assess whether BMS-817399 in combination with Methotrexate is effective in treating moderate to severe rheumatoid arthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Local Institution
      • Buenos Aires, Argentina, 1015
        • Local Institution
      • Tucuman, Argentina, 4000
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1425
        • Local Institution
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-718
        • Local Institution
      • Gwangju, Korea, Republic of, 501-757
        • Local Institution
      • Seoul, Korea, Republic of, 110-744
        • Local Institution
      • Seoul, Korea, Republic of, 143-729
        • Local Institution
  • Mexico
      • San Luis Potosi, Mexico, 78200
        • Local Institution
    • Baja California
      • Tijuana, Baja California, Mexico, 22010
        • Local Institution
    • Distrito Federal
      • D.f., Distrito Federal, Mexico, 06700
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44690
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44158
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 45050
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • Local Institution
      • Yaroslavl, Russian Federation, 150003
        • Local Institution
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0181
        • Local Institution
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, South Africa, 4001
        • Local Institution
    • Western Cape
      • Panorama, Western Cape, South Africa, 7500
        • Local Institution
      • Pinelands, Western Cape, South Africa, 7405
        • Local Institution
  • Spain
      • Cordoba, Spain, 14004
        • Local Institution
      • Santiago De Compostela, Spain, 15706
        • Local Institution
      • Sevilla, Spain, 41071
        • Local Institution
  • United States
    • California
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Research Center
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research & Consulting, LLC
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Pharma Resource

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects, 18 years of age or older, with rheumatoid arthritis (RA) for at least 6 months prior to screening
  • Subjects must have a tender joint count of at least 6 (28 joint count), swollen joint count of at least 6 (28 joint count) at screening. All subjects must have clinical evidence of synovitis in one hand/wrist at screening
  • Serum C-reactive protein (hsCRP) above upper limits of normal at screening
  • Subjects must have been treated with and tolerated Methotrexate (MTX) therapy at a weekly oral or parenteral dose ≥ 10 mg for ≥ 4 months prior to screening. Dose must be stable, with no change in route of administration, for ≥ 6 weeks prior to randomization. A MTX weekly dose as low as 7.5 mg is permitted if intolerance to doses ≥10 mg has been documented in the subject's medical history
  • Subjects must be receiving folic acid, folinic acid, or leucovorin supplementation at a stable dose for at least 4 weeks prior to randomization
  • Subjects who were previously treated with up to two tumor necrosis factor α (TNF-α) inhibitors
  • If taking antimalarials (e.g. hydroxychloroquine or chloroquine), subject must have been on a stable dose for ≥ 4 months prior to randomization
  • If taking non-steroidal anti-inflammatory drugs (NSAIDs), subjects must have been on stable doses for ≥ 2 weeks prior to randomization
  • If taking oral corticosteroids, daily doses must be ≤ 10 mg/day of prednisone or equivalent and stable for ≥ 4 weeks before randomization
  • Subject is willing to participate to the study and has signed the informed consent prior to undergoing any screening procedures
  • Women of childbearing potential (WOCBP) and men must agree to use at least two acceptable methods to avoid pregnancy for the entire study period and until 60 days (for women) and 90 days (for men) after the last dose of BMS-817399. WOCBP must have a negative urine pregnancy test at screening, randomization and at scheduled visits throughout the study

Exclusion Criteria:

  • Arthritis onset prior to 16 years of age or subjects with documented juvenile RA
  • Subjects who are bed- or wheelchair-bound
  • Subjects with other autoimmune diseases or arthritis syndromes
  • Women who are pregnant, breastfeeding or with a positive pregnancy test at screening or prior to randomization
  • Subjects who have any condition that could impact upon the absorption of study drug (i.e., gastric stapling, duodenal surgery, malabsorption syndrome)
  • Subjects with a history of, or a concurrent severe, progressive, or uncontrolled disease (other than RA) that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study
  • Subjects who have present or previous (last 5 years) malignancies, except history of cured squamous or basal skin cell carcinoma or cured breast or cervical cancer
  • Subjects at risk for tuberculosis (TB) or with evidence of TB clinical history, chest X rays or tuberculin skin test
  • Subjects with evidence of active or latent bacterial or viral infections (including human immunodeficiency virus); Positive blood screen for hepatitis B surface antigen or hepatitis C antibody
  • Subjects with any serious bacterial infection within the last 2 months, unless treated and resolved with antibiotics
  • Subjects who have clinically significant drug or alcohol abuse or known cirrhosis including alcoholic cirrhosis

  • If a subject has received any of the following treatments, the indicated washout period prior to randomization must be followed:

    1. Oral or injectable azathioprine, gold, D-Penicillamine, cyclosporine, anakinra, etanercept, parenteral or intra-articular corticosteroids: 30 days
    2. Leflunomide: 6 months unless an active washout with Cholestyramine has been performed
    3. Mycophenolate mofetil, cyclophosphamide, tacrolimus or other immunosuppressant: 3 months
    4. Adalimumab, Infliximab, Golimumab, Certolizumab pegol, Abatacept or Tocilizumab: 60 days
    5. Rituximab or any B-cell depleting agent: 1 year
  • Use CYP3A4 inhibitors or inducers during the study
  • Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x upper limit of normal (ULN), total bilirubin ≥ 1.4x ULN, estimated glomerular filtration rate (GFR) < 50 mL/min/1.73m2, hemoglobin < 10.0 g/dL, white blood cell count < 3,500/mm3, absolute neutrophil count < 1,700/mm3 or platelets < 125,000/mm3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Arm 1: Placebo
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 12 weeks
Experimental: Arm 2: BMS-817399 (200 mg)
Drug: BMS-817399
Tablets, Oral, 200 mg, twice daily, 12 weeks
Drug: BMS-817399
Tablets, Oral, 400mg, twice daily, 12 weeks
Experimental: Arm 3: BMS-817399 (400 mg)
Drug: BMS-817399
Tablets, Oral, 200 mg, twice daily, 12 weeks
Drug: BMS-817399
Tablets, Oral, 400mg, twice daily, 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) change from baseline of BMS-817399 versus placebo
Time Frame: Baseline and at 12 weeks
Baseline and at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests
Time Frame: 16 weeks
16 weeks
Proportion of subjects achieving 20% American College of Rheumatology (ACR) response in each treatment group
Time Frame: Day 15
Day 15
Proportion of subjects achieving 20% ACR response in each treatment group
Time Frame: Day 29
Day 29
Proportion of subjects achieving 20% ACR response in each treatment group
Time Frame: Day 57
Day 57
Proportion of subjects achieving 20% ACR response in each treatment group
Time Frame: Day 85
Day 85
Proportion of subjects achieving 50% ACR response in each treatment group
Time Frame: Day 15
Day 15
Proportion of subjects achieving 50% ACR response in each treatment group
Time Frame: Day 29
Day 29
Proportion of subjects achieving 50% ACR response in each treatment group
Time Frame: Day 57
Day 57
Proportion of subjects achieving 50% ACR response in each treatment group
Time Frame: Day 85
Day 85
Proportion of subjects achieving 70% ACR response in each treatment group
Time Frame: Day 15
Day 15
Proportion of subjects achieving 70% ACR response in each treatment group
Time Frame: Day 29
Day 29
Proportion of subjects achieving 70% ACR response in each treatment group
Time Frame: Day 57
Day 57
Proportion of subjects achieving 70% ACR response in each treatment group
Time Frame: Day 85
Day 85
Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI)
Time Frame: Baseline and Day 15
Baseline and Day 15
Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI)
Time Frame: Baseline and Day 29
Baseline and Day 29
Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI)
Time Frame: Baseline and Day 57
Baseline and Day 57
Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI)
Time Frame: Baseline and Day 85
Baseline and Day 85
To assess the minimum observed concentration (Cmin) of BMS-817399
Time Frame: Day 15, Day 29, Day 57 and Day 85
Day 15, Day 29, Day 57 and Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM126-004
  • 2011-002024-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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