Health Condition 1: L408- Other psoriasis
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Nizams Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed recalcitrant palmoplantar psoriasis (failure of two or more prior topical or systemic therapies or contraindication or intolerance to one or more conventional systemic therapy other than Methotrexate or Tofacitinib) Palmoplantar Pssoriasis Area and Severity Index (ppPASI) score more than or equal to 10 at Baseline Palmoplantar Investigators Global Assessment (ppIGA) score of more than or equal to 3 at Baseline Patients whose screening laboratory investigations are within normal limits Willing to provide informed consent Men who agree to use barrier method of contraception throughout the study and for at least three months after the last dose of Tofacitinib Women of reproductive potential willing to use double contraception (hormonal and barrier) throughout the study and for at least four weeks after the final dose Women of child bearing potential who have completed their family and or are surgically sterile (defined as having undergone bilateral oophorectomy or hysterectomy or bilateral tubal ligation) Post menopausal women defined as women who report at least 12 consecutive months of amenorrhoea without the use of Hormonal Replacement Therapy (HRT) Able to adhere to follow up visits
Exclusion criteria
Exclusion criteria: Prior exposure to Tofacitinib or Methotrexate for PPP in the last 3 months Known hypersensitivity to Tofacitinib or Methotrexate Use of topical corticosteroids in the last four weeks Active TB within the last three years or inadequately treated TB or positive PPD or latent TB not fully treated Clinically significant cardiac or endocrine or pulmonary or neurologic or psychiatric or hepatic or renal or haematologic or immunologic disease Malignancy within the last five years History of disseminated or recurrent severe Herpes Zoster or Herpes Simplex Pregnant or breastfeeding women Any contraindication to Tofacitinib or Methotrexate Clinically significant infection within six months History of HIV or Hepatitis B or Hepatitis C infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving ppPASI-75Timepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse eventsTimepoint: Throughout the study;Time to more than or equal to 50% ppPASI reductionTimepoint: Throughout the study;Change in DLQI scores from BaselineTimepoint: 16 weeks;Proportion of patients with Palmoplantar Investigators Global Assessment (ppIGA) score of 0 or 1Timepoint: 16 weeks;Treatment discontinuation rates due to adverse eventsTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Asiya Begum
Nizams Institute of Medical Sciences
Outcome results
None listed