Health Condition 1: null- Ankylosing spondylitis Health Condition 2: M450- Ankylosing spondylitis of multiplesites in spine
Conditions
Interventions
Intervention1: Adalimumab: Adalimumab is an anti TNF monoclonal body
Control Intervention1: not applicable: not applicable
Sponsors
CENTER FOR RHEUMATIC DISEASES
Eligibility
Inclusion criteria
Inclusion criteria: • Clinical diagnosis of AS as per rheumatologist. • Aged >=18 to • Symptomatic AS defined as satisfying 2 of the following 3 criteria anytime during the last 7 days. I. musculoskeletal axial Pain on VAS scale >= 3 cm (range 0 to 10 cm). II. Early morning stiffness >= 30 min. III. ESR >= 28 mm (fall at the end of the first hour â?? westergrenâ??s method ) and / or CRP >= 5 mg/l. • Patients requiring frequent use of NSAIDs and on a stable dose of NSAIDs for at least 4 weeks. • Duration of disease >= 2 yrs.
Exclusion criteria
Exclusion criteria: 1)Patients with arthritis due to any other cause except reactive arthritis. 2)Use of any biological agent and in particular anti TNF therapy during the previous 1 year. 3)Use of any kind of immunomodulator or immunosuppressive drugs except sulphasalzine and methotrexate during the last 3 months. 4)Use of injectable steroids within 4 weeks prior to baseline. 5)Pregnancy and patients (and their spouses) unwilling to use adequate contraceptive measures. 6)History of uncontrolled and / or unstable recent onset diseases. 7)History of any recent infection requiring antibiotics in the last 3 months. 8)History of tuberculosis irrespective of the treatment provided. 9)Hepatitis or human immunodeficiency virus; a significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, or hepatic disease; and a history of demyelinating disease or multiple sclerosis. 10)History of cancer or lymphoproliferative disease other than a successfully treated non-metastatic squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. 11)H/o surgery to spine , traumatic diseases of the spine. 12)Any kind of disqualification as per the discretion of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS 20 RESPONSETimepoint: WEEK 12, 24 AND 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS 40Timepoint: WEEK 12, 24 AND 48 | — |
Countries
India
Contacts
Public ContactDR ARVIND CHOPRA
CENTER FOR RHEUMATIC DISEASES
Outcome results
None listed