| 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 Naive 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
|
- Conaghan PG, Østergaard M, Bowes MA, Wu C, Fuerst T, van der Heijde D, Irazoque-Palazuelos F, Soto-Raices O, Hrycaj P, Xie Z, Zhang R, Wyman BT, Bradley JD, Soma K, Wilkinson B. Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate-naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques. Ann Rheum Dis. 2016 Jun;75(6):1024-33. doi: 10.1136/annrheumdis-2015-208267. Epub 2016 Jan 25.
- Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
|
| |
| Completed |
| 109 |
| 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.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Chile, Croatia, Czech Republic, Hungary, Mexico, Poland, Puerto Rico, United States |
| |
| |
| NCT01164579 |
A3921068
2010-020890-18 ( EudraCT Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| April 2015 |
