An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)
NCT ID: NCT00478660
Last Updated: 2007-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1250 participants
INTERVENTIONAL
2006-02-28
Brief Summary
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* Subjects who failed another TNF inhibitor (etanercept, infliximab)
* Subjects with advanced spinal ankylosis
* Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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adalimumab (Humira)
Eligibility Criteria
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Inclusion Criteria
* Males and females 18 years of age or older
* Diagnosis of AS according to the modified New York Criteria for Ankylosing Spondylitis 1984.24
* Documented active AS based on the opinion of a physician for at least 3 months
* Active AS with BASDAI \>= 4 at the Screening Visit
* Unsatisfactory response to standard AS therapies in accordance with the current national guidelines for treatment of AS with TNF inhibitors (if applicable) including a minimum of failing at least one NSAID. National guidelines (if applicable) must be followed if the guidelines are more strict regarding the use of TNF inhibitors for the treatment of AS
* Use of reliable method of contraception, e.g., IUDs, condoms, or hormone (oral, implantable, or injectable) contraceptives by all female subjects of childbearing potential. Subject must follow the manufacture's recommendations of contraception prior to the administration of study drug and through 150 days following the last administration of adalimumab
* Able and willing to self-administer sc injections or have available a suitable person to administer sc injections
* A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment
* Subject must be evaluated for active and latent TB infection by using a PPD skin test, T SPOT-TB test, chest x-ray and a detailed review of the subject's medical history. Guidelines regarding the treatment of latent TB must be followed prior to the administration of adalimumab
Exclusion Criteria
* Treatment within the last six weeks with infliximab or within the last three weeks with etanercept or previous treatment at any time with adalimumab
* Known allergy to excipients of adalimumab formulation
* History of or current acute inflammatory joint disease of origin other than AS, e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus etc
* Treatment with corticosteroids (prednisolone equivalents) under the following conditions:
* Dose is \>10 mg/d systemically within the 28 days before screening
* Intraarticular injections or infiltrations of peripheral joints and tendons within 28 days before or at screening
* Intraarticular injections of sacroiliac joints without therapeutic response \<=14 days before screening
* Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III-IV), recent stroke (within three months), chronic leg ulcer and any other condition (e.g., indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the study
* History of cancer or malignant lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
* History of positive serology for hepatitis B indicating active infection or history of positive serology for hepatitis C
* History of positive HIV status
* Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment
* Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g., optic neuritis, ataxia, apraxia)
* History of active tuberculosis, histoplasmosis or listeriosis
* Female subjects who are pregnant or breast-feeding
* History of clinically significant drug or alcohol abuse in the last year
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Beverly Paperiello
Role: STUDY_DIRECTOR
Abbott
Locations
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Graz, , Austria
Graz, , Austria
Innsbruck, , Austria
Vienna, , Austria
Vienna, , Austria
Aalst, , Belgium
Belsele, , Belgium
Bruges, , Belgium
Charleroi, , Belgium
Erembodegem, , Belgium
Genk, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Ostend, , Belgium
Frederiksberg, , Denmark
Holstebro, , Denmark
Kolding, , Denmark
Randers, , Denmark
Silkeborg, , Denmark
Helsinki, , Finland
Hyvinkää, , Finland
Kouvola, , Finland
Turku, , Finland
Aix-en-Provence, , France
Aix-les-Bains, , France
Amiens, , France
Angers, , France
Belfort, , France
Berck, , France
Besançon, , France
Bordeaux, , France
Boulogne-Billancourt, , France
Brest, , France
Caen, , France
Cahors, , France
Clermont-Ferrand, , France
Corbeil-Essonnes, , France
Créteil, , France
Dijon, , France
Grenoble, , France
Le Kremlin-Bicêtre, , France
Le Mans, , France
Libourne, , France
Liévin, , France
Lille, , France
Limoges, , France
Lomme, , France
Lyon, , France
Lyon, , France
Lyon, , France
Marseille, , France
Marseille, , France
Montivilliers, , France
Montpellier, , France
Mulhouse, , France
Nantes, , France
Nice, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Pau, , France
Poitiers, , France
Reims, , France
Rennes, , France
Saint-Brieuc, , France
Saint-Etienne, , France
Strasbourg, , France
Toulouse, , France
Tours, , France
Valenciennes, , France
Vandœuvre-lès-Nancy, , France
Bad, , Germany
Bad Bentheim, , Germany
Bad Bramstedt, , Germany
Bad Nauheim, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Chemnitz, , Germany
Cologne, , Germany
Cottbus, , Germany
Damp, , Germany
Dresden, , Germany
Dresden, , Germany
Duisburg, , Germany
Düsseldorf, , Germany
Erfurt, , Germany
Erlangen, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Goslar, , Germany
Göttingen, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Herne, , Germany
Hildesheim, , Germany
Hofheim, , Germany
Hoyerswerda, , Germany
Jena, , Germany
Kiel, , Germany
Leipzig, , Germany
München, , Germany
München, , Germany
Neubrandenburg, , Germany
Osnabrück, , Germany
Planegg, , Germany
Ratingen, , Germany
Regensburg, , Germany
Rostock, , Germany
Sendenhorst, , Germany
Stuttgart, , Germany
Stuttgart, , Germany
Tübingen, , Germany
Villingen, , Germany
Vogelsang/Gommern, , Germany
Würzburg, , Germany
Zerbst, , Germany
Zeven, , Germany
Athens, , Greece
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Ioannina, , Greece
Larissa, , Greece
Pátrai, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Cork, , Ireland
Dublin, , Ireland
Florence, , Italy
Monserrato, , Italy
Napoli, , Italy
Palermo, , Italy
Potenza, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Den Helder, , Netherlands
Enschede, , Netherlands
Flushing, , Netherlands
Leeuwarden, , Netherlands
Zwolle, , Netherlands
Haugesund, , Norway
Levanger, , Norway
Lillehammer, , Norway
Tromsø, , Norway
Trondheim, , Norway
A Coruña, , Spain
Alicante, , Spain
Asturias, , Spain
Barakaldo, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Burgos, , Spain
Las Palmas de Gran Canaria, , Spain
Las Palmas de Gran Canaria, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Pamplona, , Spain
Valencia, , Spain
Valladolid, , Spain
Vitoria-Gasteiz, , Spain
Vizcaya, , Spain
Zaragoza, , Spain
Eskilstuna, , Sweden
Örebro, , Sweden
Östersund, , Sweden
Vaxjo, , Sweden
Bern, , Switzerland
Zurich, , Switzerland
Zurich, , Switzerland
Aberdeen, , United Kingdom
Avon, , United Kingdom
Birmingham, , United Kingdom
Cambridge, , United Kingdom
Greater Manchester, , United Kingdom
Harrow, , United Kingdom
Huddersfield, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Merseyside, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Oxford, , United Kingdom
Portsmouth, , United Kingdom
Sheffield, , United Kingdom
Southampton, , United Kingdom
Truro, , United Kingdom
Wigan, , United Kingdom
Countries
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References
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Rudwaleit M, Van den Bosch F, Kron M, Kary S, Kupper H. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res Ther. 2010;12(3):R117. doi: 10.1186/ar3054. Epub 2010 Jun 16.
Rudwaleit M, Claudepierre P, Kron M, Kary S, Wong R, Kupper H. Effectiveness of adalimumab in treating patients with ankylosing spondylitis associated with enthesitis and peripheral arthritis. Arthritis Res Ther. 2010;12(2):R43. doi: 10.1186/ar2953. Epub 2010 Mar 15.
Rudwaleit M, Claudepierre P, Wordsworth P, Cortina EL, Sieper J, Kron M, Carcereri-De-Prati R, Kupper H, Kary S. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol. 2009 Apr;36(4):801-8. doi: 10.3899/jrheum.081048. Epub 2009 Feb 27.
Rudwaleit M, Rodevand E, Holck P, Vanhoof J, Kron M, Kary S, Kupper H. Adalimumab effectively reduces the rate of anterior uveitis flares in patients with active ankylosing spondylitis: results of a prospective open-label study. Ann Rheum Dis. 2009 May;68(5):696-701. doi: 10.1136/ard.2008.092585. Epub 2008 Jul 28.
Other Identifiers
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M05-760
Identifier Type: -
Identifier Source: org_study_id