Psoriatic Arthritis with axial (spinal) involvement MedDRA version: 21.0 Level: LLT Classification code 10037166 Term: Psoriatic spondylitis System Organ Class: 100000004859 MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Xeljanz 5 mg tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TOFACITINIB CITRATE
CAS Number: 540737-29-9
Other descriptive name: TOFACITINIB CITRATE
Concentration unit
Sponsors
Charite University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject =18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - significant acute or chronic infections including Tuberculosis, HBV/HCV/HIV and Herpes zoster as defined by protocol - pregnancy and breastfeeding - other chronic inflammatory articular disease (other than psoriasis or PsA) - treatments with DMARDs other than methotrexate or sulfasalazine (e.g. Leflunomide, Hydroxychloroquine or Apremilast) within 4 weeks prior to baseline (in case of Leflunomide either 8 weeks or 4 weeks with a standard cholestyramine wash-out). - Prior treatment with Tofacitinib or another JAK-inhibitor. - Current participation in another interventional study. If subjects participated in another study of any investigational drug, there must be an appropriate wash-out period prior to the Baseline Visit. - Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous cell or basal cell carcinoma of the cutis or carcinoma in situ of the cervix - A subject with any condition possibly affecting oral drug absorption, e.g., gastrectomy... - Significant trauma or surgery procedure within 4 weeks prior to baseline, or any planned elective surgery during the study period. - Evidence of other severe uncontrolled gastrointestinal, hepatic (serum albumin 10), renal, pulmonary, cardiovascular, nervous or endocrine disorders. - Any subject who has been vaccinated with live or attenuated vaccines within the 4 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 4 weeks after the last dose of study drug. - laboratory abnormalities as defined in protocol. - Patients who are defined as vulnerable patients according to Art. 10 REGULATION (EU) No 536/2014: patients who are institutionalized due to regulatory or juridical order; patients who are an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site; family members of the aforementioned employees or the investigator. - Patients with contraindications for the MRI including but not limited to: claustrophobia, seizure disorders, presence of an implanted electronic device (e.g., heart pacemaker, insulin pump, etc.) or metal implants not known to be MRI safe and metal foreign bodies in the patient’s body suspected to be ferromagnetic, tattoos performed with metal-containing paints or tattoos of large skin areas.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of the total Berlin MRI score for sacroiliac joints and spine as compared to baseline after 12 weeks of therapy with Tofacitinib or placebo.;Secondary Objective: Improvement of the total Berlin MRI score for SIJ and spine Improvement in ASAS, BASDAI, ASDAS-CRP Improvement of function (BASFI), axial mobility (BASMI, chest expansion), ASAS-Health Index, Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment on the NRS, physician global assessment on the NRS Improvement in C-reactive Protein Improvement in the Disease Activity Index for Psoriatic Arthritis (DAPSA), swollen joint count (SJC), tender joint count (TJC), enthesitis based on the MASES, dactylitis (count of dactylitic phalanges), PASI (Psoriasis Activity and Severity Index) ;Primary end point(s): Improvement of the total Berlin MRI score for sacroiliac joints and spine as compared to baseline after 12 weeks of therapy with Tofacitinib or Placebo (see E.2.1 and E.2.2);Timepoint(s) of evaluation of this end point: week 12 compared to week 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): see E.2.1 and E.2.2;Timepoint(s) of evaluation of this end point: see E.2.1 and E.2.2 | — |
Countries
Germany
Contacts
Public ContactDr Fabian Proft
Charite University
Outcome results
None listed