Health Condition 1: M469- Unspecified inflammatory spondylopathy
Conditions
Interventions
Intervention1: Drug Prednisolone: Tab prednisolone starting with a dose of 30 mg for 1 week,20 mg over next 1 week,15 mg over next week,10 mg over next week,7.5 mg over next 2 weeks followed by 5 mg f
Sponsors
Post Graduate Institute of Medical education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age =18 years and 2.Peripheral joint involvement= 2 swollen and tender both (currently) of 68 joint count. 3.Has received one NSAIDS for a total duration of 4 weeks with inadequate response. 4.Patient not affording biologicals recommended for the treatment for peripheral SpA.
Exclusion criteria
Exclusion criteria: 1.Presence of poorly controlled diabetes defined by HbA1c >7%. 2.Presence of active infection/recurrent infection in the past or malignancy. 3.Recent fracture (within 6 months) or hip fracture(ever). 4.Pregnancy. 5. Intramuscular steroids less than 2 weeks before. 6.Uncontrolled hypertension, defined as more than 140/90 mm Hg on more than or equal to 3 drugs. 7. Patients with current psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving ACR 50 criteria at week 24.Timepoint: 0,12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Ankylosing Spondylitis Disease Activity Score(ASDAS)Timepoint: At 0,12 and 24 weeks;ASDAS NSAID indexTimepoint: At 0,12 and 24 weeks;Bath ankylosing spondylitis disease activity index(BASDAI)- a score which is calculated on the basis of 6 questions which the patient answers. We use the hindi validated version and numerical rating score 0-10 for this.Timepoint: At 0,12 and 24 weeks;Change in Dactylitis severity score -score ranging from 0-20 is the number of digits on hands and feet with dactylitis present. If dactylitis is present severity of pain due to dactylitis using NRS is also recordedTimepoint: At 0,12 and 24 weeks;Change in MASES score -The number of painful entheses out of 13 entheses.Timepoint: At 0,12 and 24 weeks;Safety analysis for screening of side effect profile of oral steroids over a period of 6 monthsTimepoint: At 12 and 24 weeks | — |
Countries
India
Contacts
Public ContactDr Sankar J
Postgraduate Institute of Medical Education and Research
Outcome results
None listed