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) (RHAPSODY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478660
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : October 10, 2007
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Brief Summary:

Due to the rigor of the clinical development program of adalimumab for the indication of AS, the population of subjects with active AS that could enroll in previous phase 3 studies was limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study:

  • Subjects who failed another TNF inhibitor (etanercept, infliximab)
  • Subjects with advanced spinal ankylosis
  • Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: adalimumab (Humira) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)
Study Start Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Primary Outcome Measures :
  1. ASAS 20/40/50/70
  2. ASAS 5/6
  3. BASDAI score

Secondary Outcome Measures :
  1. Adverse events
  2. Laboratory data
  3. Vital signs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Able and willing to give written informed consent and to comply with the requirements of the study protocol
  • 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:

  • Prior treatment with any investigational agent within 30 days, or five half-lives of the product, which ever is longer
  • 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

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 identifier (NCT number): NCT00478660

  Hide Study Locations
Graz, Austria, A-8020
Graz, Austria, A-8036
Innsbruck, Austria, A-6020
Wien, Austria, A-1090
Wien, Austria, A-1100
Aalst, Belgium, 9300
Belsele, Belgium, B-9111
Brugge, Belgium, 8000
Charleroi, Belgium, 6000
Erembodegem, Belgium, 9320
Genk, Belgium, 3600
Gent, Belgium, B-9000
Hasselt, Belgium, B-3500
Oostende, Belgium, 8400
Frederiksberg, Denmark, DK-2000
Holstebro, Denmark, DK-7500
Kolding, Denmark, DK-6000
Randers, Denmark, DK-8900
Silkeborg, Denmark, DK-8600
Helsinki, Finland, 00280
Hyvinkaa, Finland, 05800
Kouvola, Finland, 45100
Turku, Finland, 20521
Aix En Provence, France, 13616
Aix Les Bains, France, 73106
Amiens Cedex, France, 80054
Angers Cedex 1, France, 49033
Belfort, France, 90016
Berck Cedex, France, 62608
Besancon, France, 25030
Bordeaux Cedex, France, 33076
Boulogne Billancourt, France, 92100
Brest Cedex, France, 29609
Caen-Cedex, France, 14033
Cahors, France, 46005
Clermont-ferrand, France, 63003
Corbeil Essonnes, France, 91108
Creteil, France, 94010
Dijon Cedex, France, 21033
Grenoble, France, 38043
Le Kremlin Bicetre, France, 94275
Le Mans, France, 72037
Levin Cedex, France, 62806
Libourne, France, 33505
Lille Cedex, France, 59037
Limoges, France, 87042
Lomme, France, 59462
Lyon Cedex 03, France, 69437
Lyon Cedex 07, France, 69365
Lyon, France, 69310
Marseille Cedex 5, France, 13385
Marseille Cedex, France, 13285
Montivilliers, France, 76290
Montpellier Cedex 5, France, 34295
Mulhouse Cedex, France, 68070
NANTES Cedex, France, 44035
Nice, France, 06202
Orleans Cedex 01, France, 45032
Paris Cedex 10, France, 75475
Paris Cedex 13, France, 75651
Paris, France, 75012
Paris, France, 75014
Pau Cedex, France, 64046
Poitiers, France, 86021
Reims, France, 51092
Rennes Cedex, France, 35203
Saint Brieuc Cedex 1, France, 22023
Saint Etienne, France, 42055
Strasbourg, France, 67098
Toulouse Cedex 9, France, 31059
Tours Cedex, France, 37044
Valenciennes, France, 59322
Vandoeuvre les Nancy, France, 54511
Bad Bentheim, Germany, D-48455
Bad Bramstedt, Germany, 24576
Bad Nauheim, Germany, D-61231
Bad, Germany, 83043
Berlin, Germany, 10117
Berlin, Germany, 12200
Berlin, Germany, 13055
Berlin, Germany, 13125
Berlin, Germany, D-14109
Chemnitz, Germany, D-09130
Cottbus, Germany, 03048
Damp, Germany, 24349
Dresden, Germany, 01307
Dresden, Germany, D-01067
Duisburg, Germany, 47055
Düsseldorf, Germany, 40225
Erfurt, Germany, 99096
Erlangen, Germany, 91054
Frankfurt, Germany, 60528
Freiburg, Germany, 79106
Goslar, Germany, 38640
Göttingen, Germany, 37075
Hamburg, Germany, 21075
Hamburg, Germany, 22147
Hamburg, Germany, D-22081
Hannover, Germany, 30625
Heidelberg, Germany, D-69115
Herne, Germany, 44652
Hildesheim, Germany, D-31134
Hofheim, Germany, D-65719
Hoyerswerda, Germany, 02977
Jena, Germany, D-07747
Kiel, Germany, 24116
Köln, Germany, 50924
Leipzig, Germany, 04103
München, Germany, 80639
München, Germany, 81541
Neubrandenburg, Germany, 17033
Osnabrück, Germany, D-49074
Planegg, Germany, D-82152
Ratingen, Germany, D-40882
Regensburg, Germany, 93042
Rostock, Germany, 18059
Sendenhorst, Germany, 48324
Stuttgart, Germany, 70178
Stuttgart, Germany, 70372
Tübingen, Germany, 72076
Villingen, Germany, 78054
Vogelsang/Gommern, Germany, 39245
Würzburg, Germany, D-97070
Zerbst, Germany, 39261
Zeven, Germany, 27404
Athens, Greece, 11521
Athens, Greece, 11527
Athens, Greece
Heraklion, Greece
Ioannina, Greece, 45500
Larisa, Greece, 41110
Patras, Greece, 26500
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 54642
Thessaloniki, Greece, 55134
Thessaloniki, Greece, 56403
Cork, Ireland
Dublin, Ireland, 7
Firenze, Italy, 50139
Monserrato, Italy, 09042
Napoli, Italy, 80131
Palermo, Italy, 90127
Potenza, Italy, 85100
Reggio Emilia, Italy, 42100
Roma, Italy, 00161
Den Helder, Netherlands, 1782 GZ
Enschede, Netherlands, 7511 JX
Leeuwarden, Netherlands, 8934 AD
Vlissingen, Netherlands, 4382 EE
Zwolle, Netherlands, 8011 JW
Haugesund, Norway, 5504
Levanger, Norway, 7600
Lillehammer, Norway, N-2609
Tromsø, Norway, 9038
Trondheim, Norway, N-7006
A Coruña, Spain, 15006
Alicante, Spain, 03203
Asturias, Spain, 33012
Barakaldo, Spain, 48903
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Barcelona, Spain, 08208
Barcelona, Spain, 08221
Barcelona, Spain, 08304
Burgos, Spain, 09005
Las Palmas de Gran Canaria, Spain, 35016
Las Palmas de Gran Canaria, Spain, 35020
Madrid, Spain, 28007
Madrid, Spain, 28034
Madrid, Spain, 28035
Madrid, Spain, 28041
Madrid, Spain, 28880
Pamplona, Spain, 31008
Valencia, Spain, 46017
Valladolid, Spain, 47010
Vitoria-Gasteiz, Spain, 01009
Vizcaya, Spain, 48013
Zaragoza, Spain, 50009
Eskilstuna, Sweden, SE-631 88
Växjö, Sweden, SE-351 85
Örebro, Sweden, SE- 701 85
Östersund, Sweden, SE-831 83
Bern, Switzerland, 3010
Zürich, Switzerland, 8063
Zürich, Switzerland, 8091
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Avon, United Kingdom, BA1 1RL
Birmingham, United Kingdom, B29 6JD
Cambridge, United Kingdom, CB2 2QQ
Greater Manchester, United Kingdom, M6 8HD
Harrow, United Kingdom, HA1 3UJ
Huddersfield, United Kingdom, HD3 3EA
Leeds, United Kingdom, LS7 4SA
Liverpool, United Kingdom, L9 7AL
London, United Kingdom, SE1 9RT
London, United Kingdom, SE5 9PJ
London, United Kingdom, SW10 9NH
Merseyside, United Kingdom, CH49 5PE
Newcastle upon Tyne, United Kingdom, NE7 7DN
Oxford, United Kingdom, OX3 7LD
Portsmouth, United Kingdom, PO6 3LY
Sheffield, United Kingdom, S10 2JF
Southampton, United Kingdom, SO16 6YD
Truro, United Kingdom, TR1 3LJ
Wigan, United Kingdom, WN6 9EP
Sponsors and Collaborators
Study Director: Beverly Paperiello Abbott

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00478660     History of Changes
Other Study ID Numbers: M05-760
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Anti-Inflammatory Agents
Antirheumatic Agents