Combination Disease-Modifying Antirheumatic Drugs (DMARDs) Versus Sulfasalazine in Inflammatory Back Pain
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences