Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01164579
First received: July 15, 2010
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tasocitinib plus Methotrexate
Drug: Tofacitinib plus placebo methotrexate
Drug: Placebo tofacitinib plus Methotrexate
Phase 2

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: An Exploratory Phase 2, Randomized, Double-Blind, Multicenter Study To Assess The Effects Of Tofacitinib (CP-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naïve Subjects With Early Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in OMERACT RAMRIS wrist and metacarpophalangeal (MCP) joints synovitis and bone marrow edema [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in OMERACT RAMRIS wrist joints and MCP synovitis (range 0-21) at Months 1, 6, and 12. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in OMERACT RAMRIS bone marrow edema (range 0 - 69) in MCP and wrist joints at Months 1, 3, and 12. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in OMERACT RAMRIS erosions in MCP and wrist joints, range (0-230) at all assessed time pointscentral facility. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ACR 20, ACR 50 and ACR 70 at all time points. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Modified total Sharp scores, joint space narrowing and erosion scores as ascertained from posteroanterior (PA) hand and anteroposterior (AP) foot radiographs obtained at baseline, 6 and 12 months, scored by a central facility. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving American College of Rheumatology (ACR) responder criteria at the 20%, 50% and 70% improvement levels (ACR 20, ACR 50 and ACR 70, respectively) at all time points. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Actual and change from baseline in RA disease activity, assessed as the DAS using DAS28 3 CRP) and DAS28 4 ESR and the categorization of disease activity based on DAS at all time points. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: October 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tofacitinib (CP 690,550) 10 mg BID plus MTX Drug: Tasocitinib plus Methotrexate
Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months
Experimental: Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX Drug: Tofacitinib plus placebo methotrexate
Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1.
Active Comparator: Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk Drug: Placebo tofacitinib plus Methotrexate
Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib

  Eligibility

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

Inclusion Criteria:

  • Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive.

Exclusion Criteria:

  • Pregnant or lactating patients;
  • Patients with renal or hepatic impairment or other severe or progressing disease;
  • Patients with contraindication to magnetic resonance imaging with gadolinium contrast.
  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: NCT01164579

  Show 39 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01164579     History of Changes
Other Study ID Numbers: A3921068
Study First Received: July 15, 2010
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Early Rheumatoid Arthritis
Joint Structure
Magnetic Resonance Imaging
Janus Kinase (JAK) Inhibitor
Tasocitinib
Tofacitinib

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

ClinicalTrials.gov processed this record on July 29, 2014