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

Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: diclophenac (Drug); diclophenac (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Charite University, Berlin, Germany

Official(s) and/or principal investigator(s):
Martin Rudwaleit, MD, Principal Investigator, Affiliation: Charité University, Berlin, Germany
Joachim Sieper, MD, Principal Investigator, Affiliation: Charité University, Berlin, Germany
Jürgen Braun, MD, Principal Investigator, Affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany

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.

Clinical Details

Official title: Effects of NSAIDs on RAdiographic Damage in Ankylosing Spondylitis (ENRADAS) - a Prospective Randomised Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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.

ITT analysis of radiographic change.

Change in VAS back pain, BASDAI, BASFI, BASMI, CRP.

event rates of serious and non-serious adverse events will be documented and compared between the two groups.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Brandt, Berlin 12163, Germany

Praxis Mielke, Berlin 12627, Germany

Praxis Zinke, Berlin 13055, Germany

Gemeinschaftspraxis Dr. Schwenke, Dresden 01109, Germany

Praxis Dr. Pick, Grafschaft bei Bad Neuenahr-Ahrweiler 53501, Germany

Praxis Dr. Kühne, Haldensleben 39340, Germany

Rheumazentrum Ruhrgebiet, St. Josefs Krankenhaus, Herne 44652, Germany

St. Josefs-Krankenhaus, Rheumatologie, Herne 44652, Germany

Praxis Dr. Kapelle, Hoyerswerda 02977, Germany

Gemeinschaftspraxis Dr. Kolitsch, Katzhütte 98746, Germany

Praxis Dr. Gräßler, Pirna 01796, Germany

Praxis Bohl-Bühler, Potsdam 14469, Germany

Medizinische Universitätsklinik Innere Medizin, Tübingen, Baden-Württemberg 1072076, Germany

Praxis Dr. Jacki, Tübingen, Baden-Württemberg 72072, Germany

Praxis Dr. Manger, Bamberg, Bayern 96047, Germany

Praxis Dr. Ochs, Bayreuth, Bayern 95445, Germany

Praxis Dr. Kellner, München, Bayern 80639, Germany

Praxiszentrum St. Bonifazius, München, Bayern 81541, Germany

Gemeinschaftspraxis Dr. Göttl, Passau, Bayern 94032, Germany

Fachklinik Bad Bentheim, Bad Bentheim, Niedersachsen 48455, Germany

Praxis Dr. Rockwitz, Goslar, Niedersachsen 38640, Germany

Gemeinschaftspraxis Dr. von Hinüber, Hildesheim, Niedersachsen 31134, Germany

Gemeinschaftspraxis Dr. Gauler, Osnabrück, Niedersachsen 49076, Germany

Praxis Dr. Dockhorn, Weener, Niedersachsen 26828, Germany

Rheumatologische Schwerpunktpraxis, Düsseldorf, Nordrhein-Westfalen 40217, Germany

Universitätsklinikum DüsseldorfKlink für Endokrinologie, Diabetologie und Rheumatologie, Düsseldorf, Nordrhein-Westfalen 40001, Germany

Evangelisches Krankenhaus, Ratingen, Nordrhein-Westfalen 40882, Germany

Praxis Dr. Kramer, Remscheid, Nordrhein-Westfalen 42897, Germany

Praxis Dr. Schoo, Rheine, Nordrhein-Westfalen 48431, Germany

Rheumatologische Praxis Dr. Spieler, Zerbst, Sachsen-Anhalt 39261, Germany

Additional Information

Homepage, Charité, CBF, Rheumatology

Related publications:

Wanders A, Heijde Dv, Landewé R, Béhier JM, Calin A, Olivieri I, Zeidler H, Dougados M. Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial. Arthritis Rheum. 2005 Jun;52(6):1756-65.

Starting date: September 2008
Last updated: August 22, 2014

Page last updated: August 23, 2015

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