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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01039688
First received: December 23, 2009
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Arthritis, Rheumatoid
Drug: CP-690,550
Drug: Disease-modifying antirheumatic drug
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • ACR 70 responder rate [ Time Frame: month 6 and all other timepoints ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events and clinical laboratory abnormalities [ Time Frame: all time points ] [ Designated as safety issue: Yes ]
  • Summary of changes in physical examination compared to baseline by patient [ Time Frame: all time points ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline of scores of PA hand and AP foot radiographs [ Time Frame: month 12, 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • ACR 20, 50, and 70 responder rates [ Time Frame: all time points ] [ Designated as safety issue: No ]
  • DAS 28-3 (CRP) and DAS 28-4 (CRP) [ Time Frame: all time points ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Physical function and patient reported outcomes [ Time Frame: various timepoints ] [ Designated as safety issue: No ]

Enrollment: 968
Study Start Date: January 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039688

  Show 163 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional 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
Study First Received: December 23, 2009
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 22, 2014