| A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis |
| Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Psoriasis |
- Drug: CP-690,550
10 mg oral BID, Continuous treatment for 52 Weeks
- Drug: CP-690,550
5 mg oral BID, Continuous treatment for 52 Weeks
- Drug: Placebo/CP-690,550
0 mg oral BID, Continuous treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
- Drug: Placebo/CP-690,550
0 mg oral BID, Continuous treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
|
- Experimental: Active Treatment 10 mg BID
Intervention: Drug: CP-690,550
- Experimental: ActiveTreatment 5 mg BID
Intervention: Drug: CP-690,550
- Placebo Comparator: Placebo Treatment
Interventions:
- Drug: Placebo/CP-690,550
- Drug: Placebo/CP-690,550
|
| 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. |
| |
| Completed |
| 901 |
| April 2013 |
| April 2013 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
- a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
- No evidence of active or latent tuberculosis
Exclusion Criteria:
- Non-plaque or drug induced forms of psoriasis
- cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
- any uncontrolled significant medical condition
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Canada, Colombia, Germany, Hungary, Japan, Mexico, Poland, Serbia, Taiwan, Ukraine, United States |
| |
| |
| NCT01276639 |
| A3921078 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| September 2014 |
