Health Condition 1: M609- Myositis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib: Tofacitinib (Tofajak) 5mg twice
daily, orally administered,
irrespective of meals for 24 weeks.
Control Intervention1: Conventional Synthetic
DMARDs: - Switch to conventio
Sponsors
St. Johns Medical College Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Main Inclusion criteria either 1 or 2 1 Dermatomyositis with active disease, inability to taper steroids less than 0.25 mg per kg body weight while on at least one steroid sparing IS i.e. either methotrexate or azathioprine or mycophenolate mofetil or tacrolimus at appropriate doses for at least 12 weeks AND either CDASI greater than or equal to 14 OR active muscle disease as indicated by MMT8 less than 70 or 80 plus elevated muscle enzymes greater ULN any 2 of 4 or MRI evidence of active muscle inflammation 2 Newly diagnosed Dermatomyositis with active skin disease CDASI greater than or equal to 14 with or without active muscle disease as indicated by MMT8 less than 70 or 80 plus elevated muscle enzymes greater ULN any 2 of 4 or MRI evidence of active muscle inflammation. Inclusion Criteria contd. 1 Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 2 Male or female patients aged from 18 years up to 65 years 3 Patients must fulfill Bohan and Peter criteria for Inflammatory myositis 4 Diagnosis within the last 2 years for Main Inclusion criteria 1 5 Concomitant glucocorticoid sparing treatments must be on stable doses for at least 4 weeks prior to screening 6 Willing to use effective contraception
Exclusion criteria
Exclusion criteria: 1 Severe muscle disease with respiratory muscle weakness requiring ventilatory support 2 Clinically significant ILD with FVC less than 40 percent or SaO2 at room air less than 90 percent 3 Malignancy associated inflammatory Myositis 4 Chronic hepatitis B and hepatitis C or PLHA 5 Chronic Liver disease or Chronic renal failure (eGFR) less than 60 mL per min per1.73 m2 or Severe anemia Hb less than 7gm per dl 6 Prior use of cyclophosphamide or rituximab in previous 6 months 7 Prescription of leflunomide in previous 1 month 8 Prior use of tofacitinib or any other JAK inhibitor 9 Current active tuberculosis or bacterial infection 10 Past history of allergic reactions or anaphylaxis 11 Uncontrolled diabetes mellitus or hypertension 12 Past coronary events requiring coronary intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who were able to taper steroids to less than or equal to 5mg per day at the end of 24 weeks plus At least 20 percent improvement from baseline in TIS AND OR greater than 40 percent improvement in CDASI from baseline at 24 weeksTimepoint: Proportion of patients who were able to taper steroids to less than or equal to 5mg per day at the end of 24 weeks plus At least 20 percent improvement from baseline in TIS AND OR greater than 40 percent improvement in CDASI from baseline at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with 40 percent improvement from baseline in CDASI at 24 and 48 weeks 2. Proportion of patients with TIS improvement of 40 percent at 24 and 48 weeks 3. FVC or dyspnoea scale 4. Difference in median TIS between cases and controls at 24 and 48 weeks 5. PROM based at 24 and 48 weeks 6. Physician Global Assessment based at 24 and 48 weeks 7. MMT8 based at 24 and 48 weeks 8. Time to failure to adhere to steroid taper protocol 9. Cumulative GC dose prednisolone equivalent 10. Proportion of patients requiring escape from the trial protocol Unable to follow prespecified steroid taper plan Worsening in disease activity while following the trial protocol worsening in the skin no CDASI based definition available Worsening of MMT8 by greater than 20 percent Worsening of PGA by greater than 2cm on a 10cm VAS 11. Death 12. HospitalizationTimepoint: 48 weeks | — |
Countries
India
Contacts
Public ContactNayana V
St. johns medical college hospital
Outcome results
None listed