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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 (ORAL1069)

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ClinicalTrials.gov Identifier: NCT01039688
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : May 8, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: CP-690,550 Drug: Disease-modifying antirheumatic drug Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 968 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized, Double-Blind Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Compared To Methotrexate In Methotrexate-Naive Patients With Rheumatoid Arthritis
Study Start Date : January 2010
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 5 mg BID CP-690,550 Drug: CP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months
Experimental: 10 mg BID CP-690,550 Drug: CP-690,550
Oral tablets administered at a dose of 10 mg BID for 24 months
Active Comparator: methotrexate 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

Primary Outcome Measures :
  1. Comparison of baseline and month 6 scores of PA hand and AP foot radiographs obtained, read and scored by a central facility [ Time Frame: comparison of baseline and month 6 ]
  2. ACR 70 responder rate [ Time Frame: month 6 and all other timepoints ]
  3. Incidence and severity of adverse events and clinical laboratory abnormalities [ Time Frame: all time points ]
  4. Summary of changes in physical examination compared to baseline by patient [ Time Frame: all time points ]
  5. Mean change from baseline in vital signs (blood pressure, heart rate, and temperature) measurements; categorical summary of absolute vital signs and vital sign changes compared to baseline by patient [ Time Frame: all time points ]

Secondary Outcome Measures :
  1. Change from baseline of scores of PA hand and AP foot radiographs [ Time Frame: month 12, 24 ]
  2. Patients who drop out of A3921069 early will have radiographs obtained at last study visit, if previous radiographs were obtained more than 3 months prior to end of study visit. [ Time Frame: all time points ]
  3. Period radiographs will be obtained in all patients who discontinue from this study and enroll in open-label, long-term study A3921024. Changes in joint structure seen in A3921024 will be scored using validated method, similar to that used in this study. [ Time Frame: all time points ]
  4. ACR 20, 50, and 70 responder rates [ Time Frame: all time points ]
  5. DAS 28-3 (CRP) and DAS 28-4 (CRP) [ Time Frame: all time points ]
  6. DAS 28-3 (ESR) and DAS 28-4 (ESR) at participating sites (dependent upon availability of a local laboratory that can report ESR results directly to the central laboratory, to ensure blinding of data). [ Time Frame: all time points ]
  7. Physical function and patient reported outcomes [ Time Frame: various timepoints ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01039688

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Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01039688     History of Changes
Other Study ID Numbers: A3921069
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by Pfizer:
oral JAK inhibitor
clinical trial
joint diseases
autoimmune diseases
anti-Inflammatory agents
rheumatic diseases

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors