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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00715091
• Date of registration: 14/07/2008
• Prospective Registration: Yes
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis ENRADAS
• Scientific title: Effects of NSAIDs on RAdiographic Damage in Ankylosing Spondylitis (ENRADAS) - a Prospective Randomised Controlled Trial
• Date of first enrolment: September 2008
• Target sample size: 180
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00715091
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Germany

Contacts

• Name: Joachim Sieper, MD
• Affiliation: Charité University, Berlin, Germany

• Name: Martin Rudwaleit, MD
• Affiliation: Charité University, Berlin, Germany

• Name: Jürgen Braun, MD
• Affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: diclophenac

Primary Outcome(s)

radiographic change (mean) of the spine after 2 years in the per-protocol population. Radiographs will be collected and centrally digitized. Scoring will be done by 2 readers who were blinded to treatment and sequence of the films [Time Frame: 2 years]

Secondary Outcome(s)

Change in VAS back pain, BASDAI, BASFI, BASMI, CRP. [Time Frame: 2 years]

event rates of serious and non-serious adverse events will be documented and compared between the two groups. [Time Frame: 2 years]

ITT analysis of radiographic change. [Time Frame: 2 years]

the proportions of patients with any progression (change in the mSASSS = 1) and change in the mSASSS > smallest detectable change (SDC), i.e. change in mSASSS which is greater than the measurement error. [Time Frame: 2 years]

Secondary ID(s)

EUDA-CT: 2007-007637-39

ENRADAS-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors