Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 3

Conditions: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh; Condition ...Moderate to Severe Axial Spondyloarthopathy

Treatments: Drug: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from Bangladesh

Study type: Interventional

Funder types: Other

Identifiers

NCT06985134

1638

Details and patient eligibility

About

the present study was conducted to determine the comparative efficacy and safety of thalidomide and SSZ in moderate to severe cases of ankylosing spondylitis in Bangladesh.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The present study included patients aged >18 years with inflammatory low back pain fulfilling the Modified New York criteria for moderate to severe ankylosing spondylitis. The criteria include radiographic sacroiliitis (at least grade II bilaterally or grade III unilaterally) along with clinical signs, such as inflammatory back pain for at least 3 months' duration, limitation of lumbar spine in sagittal and frontal planes, or chest expansion decreased relative to normal values for age and sex

Exclusion criteria

• Exclusion criteria were non-inflammatory back pain or back pain due to inflammatory causes other than AS, failure to confirm a washout period of four weeks, those, those who were on DMARDs, allergy to thalidomide, sulphasalazine, and NSAIDs, known to have kidney diseases or cardiac disease, active peptic ulcer disease, and pregnancy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

93 participants in 1 patient group

Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Sp

Experimental group

Treatment:

Drug: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from Bangladesh