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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Gilbert, Arizona, 85234 United States
Contact
1-800-718-1021
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 White blood cell count Platelet count

- 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

NCT00853385
Pfizer
Completed
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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A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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)
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
717
March 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00853385
A3921064
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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