Combination Disease-Modifying Antirheumatic Drugs (DMARDs) Versus Sulfasalazine in Inflammatory Back Pain
Condition: Seronegative Spondyloarthropathies
MeSH terms: Spondylitis; Spondylarthropathies; Spondylarthritis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Spondyloarthropathies SpA
    

Intervention name(s): Methotrexate, Hydroxychloroquine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Methotrexate will be prepared as unmarked tablets of 2.5 mg strength each and Hydroxychloroquine as unmarked tablet of 200 mg strength. Patients will be started on Methotrexate/placebo at 10 mg once weekly and increased every week by 2.5 mg to maximum dose of 20 mg per week in the absence of side effects. These patients will also be started on Hydroxychloroquine 200 mg per day or placebo.; Identical placebos (for methotrexate and hydroxychloroquine)will be prepared and prescribed in identical fashion as the methotrexate and hydroxychloroquine in the combination DMARD arm.
Other intervention name(s): Folitrax; HCQS
Intervention MeSH terms: Hydroxychloroquine; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; undifferentiated spondyloarthropathy; spondyloarthropathy; inflammatory back pain; methotrexate; sulfasalazine; hydroxychloroquine