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Rheumatoid ArthritisPhase 2RANCT01404585

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

A Phase 2 study testing BMS-817399 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 29 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to assess whether BMS-817399 in combination with Methotrexate is effective in treating moderate to severe rheumatoid arthritis. 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?
BMS-817399
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
123 participants
Where
29 sitesin 7 countries
Study dates
Sep 2011to Feb 2013
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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:
  • Oral or injectable azathioprine, gold, D-Penicillamine, cyclosporine, anakinra, etanercept, parenteral or intra-articular corticosteroids: 30 days
  • Leflunomide: 6 months unless an active washout with Cholestyramine has been performed
  • Mycophenolate mofetil, cyclophosphamide, tacrolimus or other immunosuppressant: 3 months
  • Adalimumab, Infliximab, Golimumab, Certolizumab pegol, Abatacept or Tocilizumab: 60 days
  • 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

Trial locations and contacts

29 sites in 7 countries.

29 sites in 7 countries

Mexico7 sites

  • Local Institution

    D.f., Mexico City, 06700

  • Local Institution

    Guadalajara, Jalisco, 44158

  • Local Institution

    Guadalajara, Jalisco, 44690

  • Local Institution

    Guadalajara, Jalisco, 45050

  • Local Institution

    Mérida, Yucatán, 97000

  • Local Institution

    San Luis Potosí City, San Luis Potosí, 78200

  • Local Institution

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

United States5 sites

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • Paramount Medical Research & Consulting, Llc

    Middleburg Heights, Ohio, 44130

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Sarasota Arthritis Research Center

    Sarasota, Florida, 34239

Other trials in United States

Argentina4 sites

  • Local Institution

    Buenos Aires, Buenos Aires, 1015

  • Local Institution

    Buenos Aires, Buenos Aires, 1426

  • Local Institution

    Capital Federal, Buenos Aires, 1425

  • Local Institution

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

South Africa4 sites

  • Local Institution

    Durban, KwaZulu-Natal, 4001

  • Local Institution

    Panorama, Western Cape, 7500

  • Local Institution

    Pinelands, Western Cape, 7405

  • Local Institution

    Pretoria, Gauteng, 0181

Other trials in South Africa

South Korea4 sites

  • Local Institution

    Daegu, 705-718

  • Local Institution

    Gwangju, 501-757

  • Local Institution

    Seoul, 110-744

  • Local Institution

    Seoul, 143-729

Other trials in South Korea

Spain3 sites

  • Local Institution

    Córdoba, 14004

  • Local Institution

    Santiago de Compostela, 15706

  • Local Institution

    Seville, 41071

Other trials in Spain

Russia2 sites

  • Local Institution

    Moscow, 115522

  • Local Institution

    Yaroslavl, 150003

Other trials in Russia

About this study

Official title: 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.

Being tested
Placebo, BMS-817399
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • PlaceboDrug

    Tablets, Oral, 0 mg, twice daily, 12 weeks

  • BMS-817399Drug

    Tablets, Oral, 200 mg, twice daily, 12 weeks

  • BMS-817399Drug

    Tablets, Oral, 400mg, twice daily, 12 weeks

Study groups in NCT01404585
Study groupRoleWhat they receive
Arm 1: PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Arm 2: BMS-817399 (200 mg)ExperimentalNot described
Receives: Drug: BMS-817399
Arm 3: BMS-817399 (400 mg)ExperimentalNot described
Receives: Drug: BMS-817399

What is being measured

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

  1. Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) change from baseline of BMS-817399 versus placebo

    Measured: Baseline and at 12 weeks

Secondary outcomes (18)

  1. Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests

    Measured: 16 weeks

  2. Proportion of subjects achieving 20% American College of Rheumatology (ACR) response in each treatment group

    Measured: Day 15

  3. Proportion of subjects achieving 20% ACR response in each treatment group

    Measured: Day 29

  4. Proportion of subjects achieving 20% ACR response in each treatment group

    Measured: Day 57

  5. Proportion of subjects achieving 20% ACR response in each treatment group

    Measured: Day 85

  6. Proportion of subjects achieving 50% ACR response in each treatment group

    Measured: Day 15

  7. Proportion of subjects achieving 50% ACR response in each treatment group

    Measured: Day 29

  8. Proportion of subjects achieving 50% ACR response in each treatment group

    Measured: Day 57

  9. Proportion of subjects achieving 50% ACR response in each treatment group

    Measured: Day 85

  10. Proportion of subjects achieving 70% ACR response in each treatment group

    Measured: Day 15

  11. Proportion of subjects achieving 70% ACR response in each treatment group

    Measured: Day 29

  12. Proportion of subjects achieving 70% ACR response in each treatment group

    Measured: Day 57

  13. Proportion of subjects achieving 70% ACR response in each treatment group

    Measured: Day 85

  14. Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI)

    Measured: Baseline and Day 15

  15. Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI)

    Measured: Baseline and Day 29

  16. Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI)

    Measured: Baseline and Day 57

  17. Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI)

    Measured: Baseline and Day 85

  18. To assess the minimum observed concentration (Cmin) of BMS-817399

    Measured: Day 15, Day 29, Day 57 and Day 85

Timeline

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

  1. First posted28 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

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
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01404585
Sponsor's protocol ID
IM126-004
Other IDs
2011-002024-40
Acronym
RA
Status last verified
Sep 2015
First submitted
27 Jul 2011
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-817399 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 29 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Mexico, United States, Argentina, South Africa, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01404585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

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