Seronegative Spondyloarthropathies Clinical Trial
Official title:
A Prospective Double Blind Placebo Controlled Trial of Combination Disease Modifying Antirheumatic Drugs (DMARDs) vs Monotherapy (Sulfasalazine) in Patients With Inflammatory Low Backache in Early Seronegative Spondylarthropathy
Till now no drug has been conclusively shown to affect the natural course of the
inflammatory back ache in seronegative spondylarthropathies. Non-steroidal anti-inflammatory
drugs (NSAIDS) have been the main stay of treatment for these diseases for long. Despite
providing good pain relief, they are largely ineffective in altering the natural course of
these diseases. However, very often, in spite of therapy, pain and discomfort continues in
these patients with recurrent exacerbations. Other drugs have been tried in these patients.
The DMARDS (Disease Modifying Anti Rheumatic Drugs) are a group of drugs which have come
into prominence following their remarkable efficacy in the management of Rheumatoid
Arthritis, another chronic inflammatory autoimmune arthritis. The major drugs which come in
this group are Methotrexate, Sulfasalazine, Hydroxychloroquine and Leflunomide. Of these
drugs, the most well studied drug in Spondylarthropathy is Sulfasalazine. Trials have shown
variable results of response of spondyloarthropathy to sulfasalazine. The other major DMARD
tried is methotrexate. Though large well controlled trials are lacking, the available data
on its efficacy in spondyloarthropathy has not been favorable. Leflunomide, the other major
DMARD has also fared poorly in a controlled trial in ankylosing spondylitis. There is at
present inadequate data regarding the efficacy of Hydroxychloroquine.
The discovery of anti TNF-α have been the major breakthrough in the management of ankylosing
spondylitis (AS) and Spondyloarthropathies (SpA). These drugs, besides providing symptomatic
improvement, also produce improvement in the indices of disease activity as Bath Ankylosing
Spondylitis Disease Activity Index (BASDAI) and the Assessment of Spondylo-Arthritis
International Society (ASAS). Besides, the enormous cost, incurred at a rate of about Rs
700,000/- per annum, put it out of reach of the majority of affected population. Add to
these is the increased risk of tuberculosis and fungal infections, a major problem in India.
In this background there is severe and pressing need for alternate safe and effective drugs
in the management of these diseases. It is here that the combination DMARD therapy assumes
importance as a potential safe and cheaper alternative.
We aim to assess the efficacy of combination DMARD therapy in patients with early
inflammatory chronic backache in patients with sero negative spondyloarthropathies.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | December 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Patients who fulfilled criteria for the diagnosis of Ankylosing Spondylitis (Modified New York Criteria) or undifferentiated spondyloarthropathy (UspA) (Amor criteria) and are within 8 years of disease onset with: - Inflammatory back Pain of more than 6 months - BASDAI =4 or EMS =45 minutes - Have failed maximum dose of at least one NSAID for 6 weeks. Exclusion Criteria: - Patients with renal diseases - patients with hepatic diseases - Patients with severe uncorrected anemia (Hb<7gm) - Patients previously received full dose of sulfasalazine and/or methotrexate with inadequate relief - Pregnant or lactating females - Malignancy or active infection - Patient requiring and affording biologicals - Patients who have received steroids in the past 3 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | UP |
| Lead Sponsor | Collaborator |
|---|---|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary end point will be number of patients attaining Assessment of spondyloarthropathy international society 20 (ASAS20) response. | 28 weeks | No | |
| Secondary | Improvement in Bath ankylosing spondylitis disease activity index (BASDAI) | 28 weeks | No | |
| Secondary | Improvement in Bath ankylosing spondylitis functional index (BASFI) | 28 weeks | No | |
| Secondary | Improvement in Bath ankylosing spondylitis metrology index (BASMI) | 28 weeks | No | |
| Secondary | Improvement in Maastricht Ankylosing Spondylitis Enthesitis Index | 28 weeks | No | |
| Secondary | Patient pain and global assessment of disease | 28 weeks | No | |
| Secondary | Physician assessment of pain and global disease | 28 weeks | No | |
| Secondary | change in Short form 36 (SF-36) and health assessment questionnaire (HAQ) parameters | 28 weeks | No | |
| Secondary | improvement in erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) | 28 weeks | No | |
| Secondary | Reduction in non steroidal anti-inflammatory drug (NSAID) dose | 28 weeks | No |