Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomised, controlled, multi-centre clinical trial on AS patients. Experimental
      intervention: continuous (daily) treatment with diclofenac cholestyramine 150 mg (Voltaren
      Resinate), divided into 75mg Voltaren twice dailyControl intervention: treatment on-demand
      (as needed) with diclofenac-cholestyramine 75 to 150 mg (Voltaren Resinate). The treatment
      strategy of the control intervention (on-demand) reflects current clinical practice in AS.
      Duration of intervention per patient: 2 years Follow-up per patient: safety assessment 3
      months after termination of the trial.
    

Detailed description: 
      Ankylosing spondylitis (AS) is a common chronic inflammatory rheumatic disease with a
      prevalence of about 0.5%. First symptoms normally occur in young adulthood. Early in its
      course, AS is dominated by chronic pain, fatigue and morning stiffness, later on by ankylosis
      and loss of function. Nonsteroidal anti-inflammatory drugs (NSAID) and tumor necrosis factor
      (TNF) alpha blocking agents are the only drugs with proven efficacy for signs and symptoms.
      It is not clear, however, whether these drugs are also capable of retarding or stopping
      structural damage, i.e. prevention of bony ankylosis. Earlier investigations indicated that
      NSAIDs have, in addition to their anti-inflammatory, also an anti-osteoproliferative effect.
      In this study we will investigate whether treatment with 150 mg diclofenac, a non-selective
      NSAID, on a daily basis (continuous treatment) over 2 years is capable to slow down the
      development of bony ankylosis as compared to treatment with 75-150mg diclofenac as needed
      according to clinical symptoms (on-demand treatment). In this national multi-centre
      randomized trial patients with symptomatic AS and indication for NSAID therapy will be
      enrolled in about 40 centres. The primary outcome parameter is the proportion of patients
      with radiographic progression in the spine after 2 years in each treatment arm. If continuous
      NSAID treatment results in less radiographic progression as compared to on-demand treatment,
      a true disease modifying effect of NSAID has to be assumed which will most likely change the
      place of NSAID treatment in AS.
    

Intervention name(s): diclophenac; diclophenac
Intervention type(s): Drug; Drug
Intervention description(s): continuous (daily) treatment of diclofenac cholestyramine 150 mg, divided into 75mg twice daily; treatment on-demand (as needed) with diclofenac-cholestyramine 75 to 150 mg daily
Other intervention name(s): voltaren resinat; Voltaren resinate
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSAIDS; ankylosing spondylitis; SpA; Spondyloarthritis; radiographic changes