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)

October 4, 2007 updated by: Abbott

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)

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)

Study Overview

Status

Completed

Conditions

Ankylosing Spondylitis

Intervention / Treatment

Drug: adalimumab (Humira)

Study Type

Interventional

Enrollment (Actual)

1250

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Graz, Austria, A-8020
  - Graz, Austria, A-8036
  - Innsbruck, Austria, A-6020
  - Wien, Austria, A-1090
  - Wien, Austria, A-1100
Belgium
- - 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
Denmark
- - Frederiksberg, Denmark, DK-2000
  - Holstebro, Denmark, DK-7500
  - Kolding, Denmark, DK-6000
  - Randers, Denmark, DK-8900
  - Silkeborg, Denmark, DK-8600
Finland
- - Helsinki, Finland, 00280
  - Hyvinkaa, Finland, 05800
  - Kouvola, Finland, 45100
  - Turku, Finland, 20521
France
- - 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, France, 69310
  - Lyon Cedex 03, France, 69437
  - Lyon Cedex 07, France, 69365
  - Marseille Cedex, France, 13285
  - Marseille Cedex 5, France, 13385
  - 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, France, 75014
  - Paris, France, 75012
  - Paris Cedex 10, France, 75475
  - Paris Cedex 13, France, 75651
  - 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
Germany
- - Bad, Germany, 83043
  - Bad Bentheim, Germany, D-48455
  - Bad Bramstedt, Germany, 24576
  - Bad Nauheim, Germany, D-61231
  - Berlin, Germany, 10117
  - Berlin, Germany, 12200
  - Berlin, Germany, 13125
  - Berlin, Germany, 13055
  - 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, 81541
  - München, Germany, 80639
  - 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
Greece
- - Athens, Greece, 11521
  - Athens, Greece, 11527
  - Athens, Greece
  - Heraklion, Greece
  - Ioannina, Greece, 45500
  - Larisa, Greece, 41110
  - Patras, Greece, 26500
  - Thessaloniki, Greece, 55134
  - Thessaloniki, Greece, 56403
  - Thessaloniki, Greece, 54642
  - Thessaloniki, Greece, 54636
Ireland
- - Cork, Ireland
  - Dublin, Ireland, 7
Italy
- - Firenze, Italy, 50139
  - Monserrato, Italy, 09042
  - Napoli, Italy, 80131
  - Palermo, Italy, 90127
  - Potenza, Italy, 85100
  - Reggio Emilia, Italy, 42100
  - Roma, Italy, 00161
Netherlands
- - Den Helder, Netherlands, 1782 GZ
  - Enschede, Netherlands, 7511 JX
  - Leeuwarden, Netherlands, 8934 AD
  - Vlissingen, Netherlands, 4382 EE
  - Zwolle, Netherlands, 8011 JW
Norway
- - Haugesund, Norway, 5504
  - Levanger, Norway, 7600
  - Lillehammer, Norway, N-2609
  - Tromsø, Norway, 9038
  - Trondheim, Norway, N-7006
Spain
- - A Coruña, Spain, 15006
  - Alicante, Spain, 03203
  - Asturias, Spain, 33012
  - Barakaldo, Spain, 48903
  - Barcelona, Spain, 08003
  - Barcelona, Spain, 08035
  - Barcelona, Spain, 08304
  - Barcelona, Spain, 08221
  - Barcelona, Spain, 08208
  - Burgos, Spain, 09005
  - Las Palmas de Gran Canaria, Spain, 35016
  - Las Palmas de Gran Canaria, Spain, 35020
  - Madrid, Spain, 28034
  - Madrid, Spain, 28041
  - Madrid, Spain, 28007
  - Madrid, Spain, 28035
  - Madrid, Spain, 28880
  - Pamplona, Spain, 31008
  - Valencia, Spain, 46017
  - Valladolid, Spain, 47010
  - Vitoria-Gasteiz, Spain, 01009
  - Vizcaya, Spain, 48013
  - Zaragoza, Spain, 50009
Sweden
- - Eskilstuna, Sweden, SE-631 88
  - Växjö, Sweden, SE-351 85
  - Örebro, Sweden, SE- 701 85
  - Östersund, Sweden, SE-831 83
Switzerland
- - Bern, Switzerland, 3010
  - Zürich, Switzerland, 8091
  - Zürich, Switzerland, 8063
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, SW10 9NH
  - London, United Kingdom, SE5 9PJ
  - 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ASAS 20/40/50/70
ASAS 5/6
BASDAI score

Secondary Outcome Measures

Outcome Measure
Adverse events
Vital signs
Laboratory data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Registration Dates

First Submitted

May 23, 2007

First Submitted That Met QC Criteria

May 23, 2007

First Posted (ESTIMATE)

May 25, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2007

Last Update Submitted That Met QC Criteria

October 4, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

M05-760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.