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Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02092467
First received: March 3, 2014
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.

Condition Intervention Phase
Arthritis, Rheumatoid
Drug: tofacitinib
Biological: adalimumab
Biological: etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 3b/4 Randomized Safety Endpoint Study Of 2 Doses Of Tofacitinib In Comparison To A Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Malignancies, excluding non-menlanoma skin cancer (NMSC) [ Time Frame: 5 years ]
    Events meeting pre-defined adjudication criteria

  • Incidence of major adverse cardiovascular events (MACE) [ Time Frame: 5 years ]
    Events meeting pre-defined adjudication criteria


Secondary Outcome Measures:
  • Opportunistic infections [ Time Frame: 5 years ]
    Adjudicated, including tuberculosis

  • Hepatic events [ Time Frame: 5 years ]
    Adjudicated

  • Cardiovascular events other than MACE [ Time Frame: 5 years ]
    Adjudicated

  • All cause mortality [ Time Frame: 5 years ]
    Adjudicated

  • Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: Month 3, 6, 9, 12, 24, 36, 48, 60 ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Month 3, 6, 9, 12, 24, 36, 48, 60 ]
    ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

  • Clinical Disease Activity Index (CDAI) [ Time Frame: Month 3, 6, 9, 12, 24, 36, 48, 60 ]
  • Simplified Disease Activity Index (SDAI) [ Time Frame: Month 3, 6, 9, 12, 24, 36, 48, 60 ]
  • ACR-EULAR Boolean remission [ Time Frame: Month 3, 6, 9, 12, 24, 36, 48, 60 ]
    Must have all of the following: < or = 1 tender joint count, < or = 1 swollen joint count, CRP < or = 1 mg/dL, patient global assessment < or = 1 on 0-10 scale

  • Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Month 3, 6, 9, 12, 24, 36, 48, 60 ]
    ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

  • Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Month 3, 6, 9, 12, 24, 36, 48, 60 ]
    ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Month 3, 6, 9, 12, 24, 36, 48, 60 ]

Estimated Enrollment: 4400
Actual Study Start Date: March 14, 2014
Estimated Study Completion Date: August 8, 2019
Estimated Primary Completion Date: August 8, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm 1 Drug: tofacitinib
Oral tablet, 5 mg BID
Experimental: Treatment Arm 2 Drug: tofacitinib
Oral tablet, 10 mg BID
Active Comparator: Treatment Arm 3
TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.
Biological: adalimumab
Pre-filled syringe, 40 mg subcutaneous injection, every other week
Other Name: Humira
Biological: etanercept
Pre-filled syringe, 50 mg subcutaneous injection, every week
Other Name: Enbrel

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe rheumatoid arthritis
  • Taking methotrexate without adequate control of symptoms
  • Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)

Exclusion Criteria:

  • Current or recent infection
  • Clinically significant laboratory abnormalities
  • Pregnancy
  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: NCT02092467

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 391 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02092467     History of Changes
Other Study ID Numbers: A3921133
2013-003177-99 ( EudraCT Number )
Study First Received: March 3, 2014
Last Updated: March 6, 2017

Keywords provided by Pfizer:
Post-marketing
Phase 4
Open-label
Safety Surveillance
CP690550
Xeljanz
oral treatment

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Etanercept
Adalimumab
Tofacitinib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 24, 2017