Trial record 1 of 1 for:
ENRADAS
Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis (ENRADAS)
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| ClinicalTrials.gov Identifier: NCT00715091 |
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Recruitment Status :
Completed
First Posted : July 15, 2008
Last Update Posted : August 25, 2014
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Sponsor:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
J. Sieper, Charite University, Berlin, Germany
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ankylosing Spondylitis | Drug: diclophenac | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of NSAIDs on RAdiographic Damage in Ankylosing Spondylitis (ENRADAS) - a Prospective Randomised Controlled Trial |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 1
continuous (daily) treatment with diclofenac cholestyramine 150 mg (Voltaren Resinate), divided into 75mg Voltaren twice daily
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Drug: diclophenac
continuous (daily) treatment of diclofenac cholestyramine 150 mg, divided into 75mg twice daily
Other Name: voltaren resinat |
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Active Comparator: 2
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.
|
Drug: diclophenac
treatment on-demand (as needed) with diclofenac-cholestyramine 75 to 150 mg daily
Other Name: Voltaren resinate |
Primary Outcome Measures :
- 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 Measures :
- 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 ]
- ITT analysis of radiographic change. [ Time Frame: 2 years ]
- 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 ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715091
Locations
Show 30 study locations
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
| Principal Investigator: | Martin Rudwaleit, MD | Charité University, Berlin, Germany | |
| Principal Investigator: | Joachim Sieper, MD | Charité University, Berlin, Germany | |
| Principal Investigator: | Jürgen Braun, MD | Rheumazentrum Ruhrgebiet, Herne, Germany |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | J. Sieper, Prof., Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00715091 |
| Other Study ID Numbers: |
ENRADAS-01 EUDA-CT: 2007-007637-39 |
| First Posted: | July 15, 2008 Key Record Dates |
| Last Update Posted: | August 25, 2014 |
| Last Verified: | August 2014 |
Keywords provided by J. Sieper, Charite University, Berlin, Germany:
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NSAIDS ankylosing spondylitis SpA Spondyloarthritis radiographic changes |
Additional relevant MeSH terms:
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Spondylitis Spondylarthritis Spondylitis, Ankylosing Bone Diseases, Infectious Infections Bone Diseases Musculoskeletal Diseases Spinal Diseases Arthritis Joint Diseases Spondylarthropathies Ankylosis |
Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |