Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

NCT01039688

Last updated date
Study Location
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, 85704, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, Rheumatoid
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.

- Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.

- Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count
<100 x 109/L


- History of any other rheumatic autoimmune disease other than Sjogren's syndrome


- No malignancy or history of malignancy


- History of infection requiring hospitalization, parenteral antimicrobial therapy, or
as otherwise judged clinically significant by the investigator, within the 6 months
prior to the first dose of study drug


- No chronic liver disease, recent or active hepatitis or other contraindication to
methotrexate therapy

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Advanced Information
Descriptive Information
Brief Title  ICMJE Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
Official Title  ICMJE Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis
Brief Summary This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: CP-690,550
    Oral tablets administered at a dose of 5 mg BID for 24 months
  • Drug: CP-690,550
    Oral tablets administered at a dose of 10 mg BID for 24 months
  • Drug: Disease-modifying antirheumatic drug
    Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
    Other Name: DMARD, MTX
Study Arms  ICMJE
  • Experimental: 5 mg BID CP-690,550
    Intervention: Drug: CP-690,550
  • Experimental: 10 mg BID CP-690,550
    Intervention: Drug: CP-690,550
  • Active Comparator: methotrexate
    Intervention: Drug: Disease-modifying antirheumatic drug
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2018)
956
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2009)
900
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
  • Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
  • Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

Exclusion Criteria:

  • Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
  • History of any other rheumatic autoimmune disease other than Sjogren's syndrome
  • No malignancy or history of malignancy
  • History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
  • No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Costa Rica,   Czechia,   Dominican Republic,   Germany,   Hungary,   India,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Peru,   Philippines,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   Thailand,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01039688
Other Study ID Numbers  ICMJE A3921069
2009-016987-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP