A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

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NCT00853385

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Study Location
Pfizer Investigational Site
Gilbert, Arizona, 85234, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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

- The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.

- The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.

- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.

- The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

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


- Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2.
White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4.
Platelet count <100,000/L


- History of any other autoimmune rheumatic 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


- Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism
related adverse event.


- Patients who have previously received adalimumab therapy for any reason.


- Patients who are contraindicated for treatment with adalimumab in accordance with the
approved local label.


- Patients meeting the New York Heart Association Class III and Class IV Congestive
Heart failure

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Official Title  ICMJE Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Brief Summary This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.
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 Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: CP 690,550
    tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
  • Drug: CP-690,550
    tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
  • Other: Placebo
    placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
  • Other: Placebo
    tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
  • Biological: Biologic TNFi
    placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months
    Other Name: Humira (Adalimumab)
Study Arms  ICMJE
  • Experimental: 5mg
    Intervention: Drug: CP 690,550
  • Experimental: 10 mg
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo Sequence 1
    Intervention: Other: Placebo
  • Placebo Comparator: Placebo Sequence 2
    Intervention: Other: Placebo
  • Active Comparator: adalimumab
    Intervention: Biological: Biologic TNFi
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: November 5, 2012)		717
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2009)		700
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ?6 joints tender or painful on motion; and ?6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
  • The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

  • Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L
  • History of any other autoimmune rheumatic 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
  • Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
  • Patients who have previously received adalimumab therapy for any reason.
  • Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
  • Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Australia,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Chile,   Costa Rica,   Croatia,   Czech Republic,   Denmark,   Dominican Republic,   Finland,   Germany,   Korea, Republic of,   Mexico,   Philippines,   Poland,   Slovakia,   Spain,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00853385
Other Study ID Numbers  ICMJE A3921064
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 January 2013

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