Health Condition 1: null- Stable patients with axial spondyloarthropathy.
Conditions
Interventions
Intervention1: Drug prednisolone: Tablet prednisolone will be given starting with 60 mg for one week followed by 40 mg for one week, 30 mg for one week, 20 mg for one week,15 mg for one week and 10 mg
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years and 2) Peripheral joint involvement 3) Has received at least one NSAIDs for a total duration of at least 4 weeks and has active disease defined by BASDAI >= 4. 5) Patient not affording for biologicals like TNF inhibitors or IL-17 inhibitors recommended for treatment of axSpA. 6) Patients having inadequate response to NSAIDs. 7)Patient who had inadequate response to prior TNF inhibitors or IL-17 inhibitors, provided they have obtained the last dose one half life before. During study period use of NSAID will be on demand as per patient upto maximal dose. Patient who are on sulfasalazine or methotrexate for any indication are allowed to continue the same without any change, on stable dose of same for 4 weeks.
Exclusion criteria
Exclusion criteria: 1) Presence of uncontrolled or poorly controlled diabetes defined by HbA1c > 7%. 2) Presence of any active infection or malignancy. 3) Recent fracture (within 6months) or hip fracture (ever). 4) Pregnancy 5) Have received intra articular or intra muscular steroids less than 4 weeks before. 6) Uncontrolled hypertension, defined as blood pressure more than systolic 140 and/or diastolic 90, on more than or equal to 3 drugs. 7) Presence of overt psoriasis or inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Will be proportion of patients achieving 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 24 in both the groups. This is defined as atleast a 50 % reduction in the score of BASDAI at baseline. BASDAI is the â??Bath Ankylosing Disease Activity Indexâ?? â?? a score which is calculated on the basis of 6 questions which the patient answers â?? we will use the hindi validated version and numerical rating score 0-10 for this. Timepoint: at baseline,12 weeks and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ankylosing Spondylitis Disease Activity Score (ASDAS)Timepoint: at baseline, 12 weeks and 24 weeks;Assessment of Spondyloarthritis international society (ASAS) 20,40, 5/6 and partial remission criteriaTimepoint: at baseline, 12 weeks and 24 weeks;BAS Global is at 0,12 and 24 weeks (Hindi validated version) Consists of single question to assess overall global wellness of the patient.( Timepoint: at baseline, 12 weeks and 24 weeks;BASFI (Bath ankylosing spondylitis functional index)â?? This consists of 10 questions on the ease of doing activities like bathing, putting socks, picking objects from ground etc.Timepoint: at bseline,12 weeks and 24 weeks;BASMI (Bath ankylosing spondylitis metrology index)â?? This consists of measurements of spinal flexion (lateral lumbar and lumbar flexion), hip movements (tragus to wall and inter malleolar distance) and neck movements (cervical rotation).Timepoint: at baseline and 24 weeks;screening for subjective and objective side effect profile of oral steriods when given for a period of 6 months.Timepoint: at 12 weeks and 24 weeks | — |
Countries
India
Contacts
Public ContactDebasish Mishra
PGIMER Chandigarh
Outcome results
None listed