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ORAL 1069

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oral 1069

 

Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, Tasocitinib (CP-690,550), To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX (ORAL1069)

Purpose

This study is designed to compare the effectiveness of the experimental drug, tasocitinib (CP-690,550), to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of tasocitinib (CP-690,550) with methotrexate.

Condition

Intervention

Phase

Arthritis, Rheumatoid Drug: Tasocitinib (CP-690,550)
Drug: Placebo		 Phase 3

Study Type: Interventional

Study Design:Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Official Title:Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of Tasocitinib (CP-690,550) In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Joint Disorders Rheumatoid Arthritis X-Rays
Drug Information available for: Methotrexate
U.S. FDA Resources

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 ]

 

Estimated Enrollment: 900
Study Start Date: January 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

 

Arms

Assigned Interventions

5 mg BID tasocitinib (CP-690,550):
Experimental

Drug: Tasocitinib (CP-690,550)

Oral tablets administered at a dose of 5 mg BID for 24 months

10 mg BID tasocitinib (CP-690,550):
Experimental

Drug: Tasocitinib (CP-690,550)

Oral tablets administered at a dose of 10 mg BID for 24 months
methotrexate:
Active Comparator

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

 

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

This information is also available at ClinicalTrials.gov.