Role of infliximab treatment in improvement of functional status of patients suffering from ankylosing spondylitis.
- Conditions
- Health Condition 1: M459- Ankylosing spondylitis of unspecified sites in spineHealth Condition 2: null- Patients with clinical symptoms and radiologically confirmed Ankylosing Spodylitis
- Registration Number
- CTRI/2017/09/009646
- Lead Sponsor
- IPGMER SSKM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. ASAS criteria fulfilled AS patients.
2. Disease causing significant functional limitation.
3. Active disease for >= 4weeks
4. BASDAI >= 4
5. Failed adequate NSAIDs trial.
6. Patients giving consent for the study.
7. Patient mentally sound enough to communicate and participate in the study and can understand the parameters well.
1. Active infection or septicaemia.
2. Documented Hypersensitivity.
3. Pregnancy.
4. Recent history of malignancy.
5. History of TB in recent past.
6. Congestive cardiac failure (NYHA Class III-IV).
7. Patients with Post myocardial infarction, Post stroke, Post mastectomy, prolonged immobilization.
8. The presence of an unstable medical condition or a known uncontrolled systemic disease, including cancer, diabetes, endocrine disease, major depression, schizophrenia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bath Ankylosing Spondylitis Functional Index (BASFI).Timepoint: At baseline, 2/6/12 weeks after initiation of treatment.
- Secondary Outcome Measures
Name Time Method VAS score (0 to 10) for back pain.Timepoint: At baseline, 2/6/12 weeks after initiation of treatment.