A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
Summary
The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
Timeline
- Start
- 2011-03
- Primary completion
- 2013-04
- Completion
- 2013-04
Outcome
Met primary endpoint
registry analysis (superiority or other test); CP-690,550 5 mg vs Placebo; p <0.0001; Odds Ratio (OR) 6.46 (95% CI 4.40 to 15.03); NCT01276639 ↗
registry analysis (superiority or other test); CP-690,550 10 mg vs Placebo; p <0.0001; Odds Ratio (OR) 12.45 (95% CI 9.01 to 31.88); NCT01276639 ↗
registry analysis (superiority or other test); CP-690,550 5 mg vs Placebo; p <0.0001; Odds Ratio (OR) 8.93 (95% CI 5.25 to 21.84); NCT01276639 ↗
registry analysis (superiority or other test); CP-690,550 10 mg vs Placebo; p <0.0001; Odds Ratio (OR) 20.81 (95% CI 11.90 to 49.86); NCT01276639 ↗
Publications
- Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
- Wolk R, Armstrong EJ, Hansen PR, Thiers B, Lan S, Tallman AM, Kaur M, Tatulych S. Effect of tofacitinib on lipid levels and lipid-related parameters in patients with moderate to severe psoriasis. J Clin Lipidol. 2017 Sep-Oct;11(5):1243-1256. doi: 10.1016/j.jacl.2017.06.012. Epub 2017 Jun 24.
- Merola JF, Elewski B, Tatulych S, Lan S, Tallman A, Kaur M. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017 Jul;77(1):79-87.e1. doi: 10.1016/j.jaad.2017.01.053. Epub 2017 Apr 7.
- Tan H, Valdez H, Griffins CE, Mrowietz U, Tallman A, Wolk R, Gordon K. Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2017 Feb;28(1):3-7. doi: 10.1080/09546634.2016.1214671. Epub 2016 Aug 18.
- Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, Langley R, Luger T, Thaci D, Buonanno M, Gupta P, Proulx J, Lan S, Wolk R; OPT Pivotal 1 and OPT Pivotal 2 investigators. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61. doi: 10.1111/bjd.14018.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tofacitinib | Small molecule | 5 mg | Oral |
| Subject | Tofacitinib | Small molecule | 10 mg | Oral |