Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Cholestyramine Resin; Diclofenac

Criteria

Inclusion Criteria:

• AS according to mod. New York criteria

• Patients must have radiographic damage (at least one syndesmophyte) of the spine but no complete ankylosis of the cervical and lumbar spine (these are patients at risk for further and more rapid radiographic progression)

• Patients must have active disease at inclusion defined as BASDAI question 2 (related to back pain) >= 4 (VAS, range 0-10) without NSAID treatment and with a clinical indication for NSAID therapy based on signs and symptoms

Exclusion Criteria:

• No radiographic damage (syndesmophyte) of the spine at baseline

• Complete ankylosis of the cervical and lumbar spine

• Inactive disease

• Evidence of current or past peptic ulcer

• Current or past coronary heart disease

• Stroke or transient ischemic attack

• Uncontrolled hypertension

• Chronic renal failure (creatinine > 1.5mg/dl)

• Impaired liver function

• Pregnancy

• Abnormal liver function (2x upper limit of normal)

• Active hepatitis B or C, chronic or acute heart failure (NYHA III or IV) -

• History of HIV infection

• History of neoplastic disease (details please refer to exclusion criteria)

• History of abuse of "hard" drugs or alcoholism

• Concomitant treatment with steroids, TNF-blockers, other DMARDs