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

July 15, 2010
January 2, 2014
October 2010
November 2013   (final data collection date for primary outcome measure)
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 ]
Change from baseline in OMERACT RAMRIS wrist synovitis. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01164579 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in OMERACT RAMRIS wrist synovitis (range 0 9) at all assessed time points. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in OMERACT RAMRIS bone marrow edema (range 0 - 69) and erosions (MCPs 2 5 and wrist joints, range 0 230) at all assessed time points. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Modified total Sharp scores, joint space narrowing and erosion scores as ascertained from 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 ACR 20, ACR 50 and ACR 70 at all time points. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Actual and change from baseline in disease activity, assessed as 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 ]
  • Incidence and severity of AEs. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence and severity of clinical laboratory abnormalities. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • 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.
  • 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
  • Experimental: Tofacitinib (CP 690,550) 10 mg BID plus MTX
    Intervention: Drug: Tasocitinib plus Methotrexate
  • Experimental: Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX
    Intervention: Drug: Tofacitinib plus placebo methotrexate
  • Active Comparator: Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk
    Intervention: Drug: Placebo tofacitinib plus Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Mexico,   Poland,   Argentina,   Hungary,   Chile,   Croatia,   Puerto Rico
 
NCT01164579
A3921068
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP