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An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01909427
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Placebo Drug: CNTO 6785 200 mg Drug: CNTO 6785 100 mg Drug: CNTO 6785 50 mg Drug: CNTO 6785 15 mg Drug: Methotrexate (MTX) Phase 2

Detailed Description:
This is a randomized (participants are assigned to treatment by chance), double-blind (participants and study personnel will not know which treatments are being given), placebo-controlled (a placebo appears identical to a study drug but has no active ingredients), multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. Approximately 250 participants with active RA despite MTX therapy will be randomly assigned to receive placebo or CNTO 6785 during the double-blind treatment phase. The maximum period of active treatment will be 28 weeks. The maximum duration of study participation will be 44 weeks. Participant safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO 6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo/CNTO 6785 200 mg+Methotrexate (MTX) Drug: Placebo
Placebo subcutaneous injections (SC) every 4 weeks through Week 12

Drug: CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28

Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.

Experimental: CNTO 6785 200 mg+MTX Drug: CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks through Week 28

Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.

Experimental: CNTO 6785 100 mg+MTX Drug: CNTO 6785 100 mg
CNTO 6785 100 mg SC every 4 weeks through Week 28

Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.

Experimental: CNTO 6785 50 mg+MTX Drug: CNTO 6785 50 mg
CNTO 6785 50 mg SC every 4 weeks through Week 28

Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.

Experimental: CNTO 6785 15 mg+MTX Drug: CNTO 6785 15 mg
CNTO 6785 15 mg SC every 4 weeks through Week 28

Drug: Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.




Primary Outcome Measures :
  1. The proportion of participants who achieve an ACR 20 response at Week 16 [ Time Frame: Week 16 ]
    American College of Rheumatology (ACR) 20 response is a >=20% improvement in rheumatoid arthritis (RA) symptoms.


Secondary Outcome Measures :
  1. Change from baseline in DAS28 (CRP) at Week 16 [ Time Frame: Baseline to Week 16 ]
    DAS28 (using CRP [C-reactive protein]) is a measure of tender and swollen joints and the patient's assessment of disease activity.

  2. The proportion of participants who achieve ACR 50 response at Week 16 [ Time Frame: Week 16 ]
    American College of Rheumatology (ACR) 50 response is a >=50% improvement in rheumatoid arthritis (RA) symptoms.

  3. The proportion of participants who achieve ACR 20 response through Week 32 [ Time Frame: Week 32 ]
  4. The proportion of participants who achieve ACR 50 response through Week 32 [ Time Frame: Week 32 ]
  5. The proportion of participants who achieve ACR 70 response through Week 32 [ Time Frame: Week 32 ]
    American College of Rheumatology (ACR) 70 response is a >=70% improvement in rheumatoid arthritis (RA) symptoms.

  6. Change from baseline of DAS28 (CRP) through Week 32 [ Time Frame: Baseline to Week 32 ]
  7. The proportion of participants with DAS28 (CRP) response through Week 32 [ Time Frame: Week 32 ]
    DAS28 (using CRP [C-reactive protein]) response is improvement from baseline, with >1.2 indicating a good or moderate response and <=0.6 indicating no response.

  8. The proportion of participants with DAS28 (CRP) remission at Week 16 [ Time Frame: Week 16 ]
    DAS28 (using CRP [C-reactive protein]) remission is defined as a value of <2.6 on the Disease Activity Index, a measure of tender and swollen joints and the patient's assessment of disease activity.

  9. The proportion of participants with DAS28 (CRP) remission at Week 32 [ Time Frame: Week 32 ]
  10. Change from baseline in DAS28 (ESR) at Week 16 [ Time Frame: Baseline to Week 16 ]
    DAS28 (using erythrocyte sedimentation rate) is a measure of tender and swollen joints and the patient's assessment of disease activity.

  11. Change from baseline in DAS28 (ESR) at Week 32 [ Time Frame: Baseline to Week 32 ]
  12. Change from baseline in HAQ-DI score through Week 32 [ Time Frame: Baseline to Week 32 ]
    The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas, each scored from 0 (no difficulty) to 3 (inability to perform a task).

  13. Change from baseline in SF-36 at Week 16 [ Time Frame: Baseline to Week 16 ]
    The SF-36 is a medical outcome study health measure and consists of 8 multi-item scales that are scored from 0 to 100, with higher scores indicating better health.

  14. Change from baseline in SF-36 at Week 32 [ Time Frame: Baseline to Week 32 ]
  15. Change from baseline in CDAI at Week 16 [ Time Frame: Baseline to Week 16 ]
    Clinical Disease Activity Index (CDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, and Physician's Global Assessments of Disease Activity.

  16. Change from baseline in CDAI at Week 32 [ Time Frame: Baseline to Week 32 ]
  17. Change from baseline in SDAI at Week 16 [ Time Frame: Baseline to Week 16 ]
    The Simplified Disease Activity Index (SDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, Physician's Global Assessments of Disease Activity, and CRP.

  18. Change from baseline in SDAI at Week 32 [ Time Frame: Baseline to Week 32 ]
  19. The proportion of participants with SDAI-based ACR/EULAR remission at Week 16 [ Time Frame: Week 16 ]
    The Simplified Disease Activity Index (SDAI)-based ACR/EULAR (European League Against Rheumatism) remission is defined as a SDAI value of <=3.3 at a visit.

  20. The proportion of participants with SDAI-based ACR/EULAR remission at Week 32 [ Time Frame: Week 32 ]
  21. The proportion of participants with Boolean-based ACR/EULAR remission at Week 16 [ Time Frame: Week 16 ]
    Boolean-based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 mg/dL; and Patient's Global Assessment of Disease Activity on VAS <=1 on a 0 to 10 scale.

  22. The proportion of participants with Boolean-based ACR/EULAR remission at Week 32 [ Time Frame: Week 32 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
  • Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
  • Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent

Exclusion Criteria:

  • Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
  • Has a diagnosis of fibromyalgia
  • Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
  • At screening, the results of laboratory tests must meet protocol-specified criteria
  • Has ever received any approved or investigational biologic agent for a rheumatic indication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909427


Locations
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Argentina
Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Cordoba, Argentina
La Capital, Argentina
San Juan, Argentina
Colombia
Barranquilla, Colombia
Bogota, Colombia
Medellín, Colombia
Czech Republic
Jihlava, Czech Republic
Praha 5, Czech Republic
Praha, Czech Republic
Philippines
Cebu, Philippines
Iloilo City, Philippines
Lipa City, Philippines
Quezon City, Philippines
Poland
Bydgoszcz, Poland
Grodzisk Mazowiecki, Poland
Lodz, Poland
Lublin, Poland
Poznan, Poland
Warszawa, Poland
Wroclaw, Poland
Russian Federation
Barnaul, Russian Federation
Ekaterinburg, Russian Federation
Kemerovo, Russian Federation
Kursk, Russian Federation
Moscow, Russian Federation
Novosibirsk, Russian Federation
Petrozavodsk, Russian Federation
Saint-Petersburg, Russian Federation
St. Petersburg, Russian Federation
Yaroslavl, Russian Federation
Thailand
Bangkok, Thailand
Chiang Mai, Thailand
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01909427    
Other Study ID Numbers: CR100935
CNTO6785ARA2001 ( Other Identifier: Janssen Research & Development, LLC )
2012-003629-40 ( EudraCT Number )
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016
Keywords provided by Janssen Research & Development, LLC:
Active rheumatoid arthritis despite methotrexate therapy
CNTO 6785
Methotrexate
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors