Clinical Effectiveness of Adalimumab (Exemptiaâ?¢) in patients suffering from symptomatic Ankylosing Spondylitis (AS) under supervised standard rheumatology care
- Conditions
- Health Condition 1: null- Ankylosing spondylitisHealth Condition 2: M450- Ankylosing spondylitis of multiplesites in spine
- Registration Number
- CTRI/2018/02/012018
- Lead Sponsor
- CENTER FOR RHEUMATIC DISEASES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
•Clinical diagnosis of AS as per rheumatologist.
•Aged >=18 to <= 75 years.
•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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ASAS 20 RESPONSETimepoint: WEEK 12, 24 AND 48
- Secondary Outcome Measures
Name Time Method ASAS 40Timepoint: WEEK 12, 24 AND 48