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Ankylosing SpondylitisPhase 4ENRADASNCT00715091

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

A Phase 4 study testing diclophenac in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 30 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
diclophenac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
30 sitesGermany
Study dates
Sep 2008to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Germany30 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455

  • Praxis Dr. Manger

    Bamberg, Bavaria, 96047

  • Praxis Dr. Ochs

    Bayreuth, Bavaria, 95445

  • Brandt

    Berlin, 12163

  • Praxis Mielke

    Berlin, 12627

  • Praxis Zinke

    Berlin, 13055

  • Gemeinschaftspraxis Dr. Schwenke

    Dresden, 01109

  • Universitätsklinikum DüsseldorfKlink für Endokrinologie, Diabetologie und Rheumatologie

    Düsseldorf, North Rhine-Westphalia, 40001

  • Rheumatologische Schwerpunktpraxis

    Düsseldorf, North Rhine-Westphalia, 40217

  • Praxis Dr. Rockwitz

    Goslar, Lower Saxony, 38640

  • Praxis Dr. Pick

    Grafschaft Bei Bad Neuenahr-Ahrweiler, 53501

  • Praxis Dr. Kühne

    Haldensleben I, 39340

  • Rheumazentrum Ruhrgebiet, St. Josefs Krankenhaus

    Herne, 44652

  • St. Josefs-Krankenhaus, Rheumatologie

    Herne, 44652

  • Gemeinschaftspraxis Dr. von Hinüber

    Hildesheim, Lower Saxony, 31134

  • Praxis Dr. Kapelle

    Hoyerswerda, 02977

  • Gemeinschaftspraxis Dr. Kolitsch

    Katzhütte, 98746

  • Praxis Dr. Kellner

    München, Bavaria, 80639

  • Praxiszentrum St. Bonifazius

    München, Bavaria, 81541

  • Gemeinschaftspraxis Dr. Gauler

    Osnabrück, Lower Saxony, 49076

  • Gemeinschaftspraxis Dr. Göttl

    Passau, Bavaria, 94032

  • Praxis Dr. Gräßler

    Pirna, 01796

  • Praxis Bohl-Bühler

    Potsdam, 14469

  • Evangelisches Krankenhaus

    Ratingen, North Rhine-Westphalia, 40882

  • Praxis Dr. Kramer

    Remscheid, North Rhine-Westphalia, 42897

  • Praxis Dr. Schoo

    Rheine, North Rhine-Westphalia, 48431

  • Medizinische Universitätsklinik Innere Medizin

    Tübingen, Baden-Wurttemberg, 1072076

  • Praxis Dr. Jacki

    Tübingen, Baden-Wurttemberg, 72072

  • Praxis Dr. Dockhorn

    Weener, Lower Saxony, 26828

  • Rheumatologische Praxis Dr. Spieler

    Zerbst, Saxony-Anhalt, 39261

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
diclophenac
Keywords
NSAIDS, ankylosing spondylitis, SpA, Spondyloarthritis, radiographic changes
Medical subject headings
Spondylitis, Ankylosing, Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diclophenacDrug

    Also called voltaren resinat

    continuous (daily) treatment of diclofenac cholestyramine 150 mg, divided into 75mg twice daily

  • diclophenacDrug

    Also called Voltaren resinate

    treatment on-demand (as needed) with diclofenac-cholestyramine 75 to 150 mg daily

Study groups in NCT00715091
Study groupRoleWhat they receive
1Experimentalcontinuous (daily) treatment with diclofenac cholestyramine 150 mg (Voltaren Resinate), divided into 75mg Voltaren twice daily
Receives: Drug: diclophenac
2Active comparatortreatment 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.
Receives: Drug: diclophenac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (4)

  1. 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.

    Measured: 2 years

  2. ITT analysis of radiographic change.

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00715091
Sponsor's protocol ID
ENRADAS-01
Other IDs
EUDA-CT: 2007-007637-39
Acronym
ENRADAS
Status last verified
Aug 2014
First submitted
14 Jul 2008
Last updated
25 Aug 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Wanders A, Heijde Dv, Landewe R, Behier 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. doi: 10.1002/art.21054.

    PubMed 15934081

  • Hartl A, Sieper J, Syrbe U, Listing J, Hermann KG, Rudwaleit M, Poddubnyy D. Serum levels of leptin and high molecular weight adiponectin are inversely associated with radiographic spinal progression in patients with ankylosing spondylitis: results from the ENRADAS trial. Arthritis Res Ther. 2017 Jun 15;19(1):140. doi: 10.1186/s13075-017-1350-9.

    PubMed 28619118

  • Sieper J, Listing J, Poddubnyy D, Song IH, Hermann KG, Callhoff J, Syrbe U, Braun J, Rudwaleit M. Effect of continuous versus on-demand treatment of ankylosing spondylitis with diclofenac over 2 years on radiographic progression of the spine: results from a randomised multicentre trial (ENRADAS). Ann Rheum Dis. 2016 Aug;75(8):1438-43. doi: 10.1136/annrheumdis-2015-207897. Epub 2015 Aug 4.

    PubMed 26242443

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing diclophenac in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 30 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00715091, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.

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