Ankylosing SpondylitisPhase 3RHAPSODYNCT00478660
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)
A Phase 3 study testing adalimumab (Humira) in people with Ankylosing Spondylitis, run by Abbott at 205 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- adalimumab (Humira)
- How many people
- 1,250 participants
- Where
- 205 sitesin 15 countries
- Study dates
- Feb 2006to not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
205 sites in 15 countries.
205 sites in 15 countries
Germany52 sites
Study site
Bad, 83043
Study site
Bad Bentheim, D-48455
Study site
Bad Bramstedt, 24576
Study site
Bad Nauheim, D-61231
Study site
Berlin, 10117
Study site
Berlin, 12200
Study site
Berlin, 13055
Study site
Berlin, 13125
Study site
Berlin, D-14109
Study site
Chemnitz, D-09130
Study site
Cologne, 50924
Study site
Cottbus, 03048
Study site
Damp, 24349
Study site
Dresden, 01307
Study site
Dresden, D-01067
Study site
Duisburg, 47055
Study site
Düsseldorf, 40225
Study site
Erfurt, 99096
Study site
Erlangen, 91054
Study site
Frankfurt, 60528
Study site
Freiburg im Breisgau, 79106
Study site
Goslar, 38640
Study site
Göttingen, 37075
Study site
Hamburg, 21075
Study site
Hamburg, 22147
Study site
Hamburg, D-22081
Study site
Hanover, 30625
Study site
Heidelberg, D-69115
Study site
Herne, 44652
Study site
Hildesheim, D-31134
Study site
Hofheim, D-65719
Study site
Hoyerswerda, 02977
Study site
Jena, D-07747
Study site
Kiel, 24116
Study site
Leipzig, 04103
Study site
München, 80639
Study site
München, 81541
Study site
Neubrandenburg, 17033
Study site
Osnabrück, D-49074
Study site
Planegg, D-82152
Study site
Ratingen, D-40882
Study site
Regensburg, 93042
Study site
Rostock, 18059
Study site
Sendenhorst, 48324
Study site
Stuttgart, 70178
Study site
Stuttgart, 70372
Study site
Tübingen, 72076
Study site
Villingen, 78054
Study site
Vogelsang/Gommern, 39245
Study site
Würzburg, D-97070
Study site
Zerbst, 39261
Study site
Zeven, 27404
France50 sites
Study site
Aix-en-Provence, 13616
Study site
Aix-les-Bains, 73106
Study site
Amiens, 80054
Study site
Angers, 49033
Study site
Belfort, 90016
Study site
Berck, 62608
Study site
Besançon, 25030
Study site
Bordeaux, 33076
Study site
Boulogne-Billancourt, 92100
Study site
Brest, 29609
Study site
Caen, 14033
Study site
Cahors, 46005
Study site
Clermont-Ferrand, 63003
Study site
Corbeil-Essonnes, 91108
Study site
Créteil, 94010
Study site
Dijon, 21033
Study site
Grenoble, 38043
Study site
Le Kremlin-Bicêtre, 94275
Study site
Le Mans, 72037
Study site
Libourne, 33505
Study site
Liévin, 62806
Study site
Lille, 59037
Study site
Limoges, 87042
Study site
Lomme, 59462
Study site
Lyon, 69310
Study site
Lyon, 69365
Study site
Lyon, 69437
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Marseille, 13285
Study site
Marseille, 13385
Study site
Montivilliers, 76290
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Montpellier, 34295
Study site
Mulhouse, 68070
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Nantes, 44035
Study site
Nice, 06202
Study site
Orléans, 45032
Study site
Paris, 75012
Study site
Paris, 75014
Study site
Paris, 75475
Study site
Paris, 75651
Study site
Pau, 64046
Study site
Poitiers, 86021
Study site
Reims, 51092
Study site
Rennes, 35203
Study site
Saint-Brieuc, 22023
Study site
Saint-Etienne, 42055
Study site
Strasbourg, 67098
Study site
Toulouse, 31059
Study site
Tours, 37044
Study site
Valenciennes, 59322
Study site
Vandœuvre-lès-Nancy, 54511
Spain23 sites
Study site
A Coruña, 15006
Study site
Alicante, 03203
Study site
Asturias, 33012
Study site
Barakaldo, 48903
Study site
Barcelona, 08003
Study site
Barcelona, 08035
Study site
Barcelona, 08208
Study site
Barcelona, 08221
Study site
Barcelona, 08304
Study site
Burgos, 09005
Study site
Las Palmas de Gran Canaria, 35016
Study site
Las Palmas de Gran Canaria, 35020
Study site
Madrid, 28007
Study site
Madrid, 28034
Study site
Madrid, 28035
Study site
Madrid, 28041
Study site
Madrid, 28880
Study site
Pamplona, 31008
Study site
Valencia, 46017
Study site
Valladolid, 47010
Study site
Vitoria-Gasteiz, 01009
Study site
Vizcaya, 48013
Study site
Zaragoza, 50009
United Kingdom20 sites
Study site
Aberdeen, AB25 2ZN
Study site
Avon, BA1 1RL
Study site
Birmingham, B29 6JD
Study site
Cambridge, CB2 2QQ
Study site
Greater Manchester, M6 8HD
Study site
Harrow, HA1 3UJ
Study site
Huddersfield, HD3 3EA
Study site
Leeds, LS7 4SA
Study site
Liverpool, L9 7AL
Study site
London, SE1 9RT
Study site
London, SE5 9PJ
Study site
London, SW10 9NH
Study site
Merseyside, CH49 5PE
Study site
Newcastle upon Tyne, NE7 7DN
Study site
Oxford, OX3 7LD
Study site
Portsmouth, PO6 3LY
Study site
Sheffield, S10 2JF
Study site
Southampton, SO16 6YD
Study site
Truro, TR1 3LJ
Study site
Wigan, WN6 9EP
Greece11 sites
Study site
Athens, 11521
Study site
Athens, 11527
Study site
Athens
Study site
Heraklion
Study site
Ioannina, 45500
Study site
Larissa, 41110
Study site
Pátrai, 26500
Study site
Thessaloniki, 54636
Study site
Thessaloniki, 54642
Study site
Thessaloniki, 55134
Study site
Thessaloniki, 56403
Belgium9 sites
Study site
Aalst, 9300
Study site
Belsele, B-9111
Study site
Bruges, 8000
Study site
Charleroi, 6000
Study site
Erembodegem, 9320
Study site
Genk, 3600
Study site
Ghent, B-9000
Study site
Hasselt, B-3500
Study site
Ostend, 8400
Italy7 sites
Study site
Florence, 50139
Study site
Monserrato, 09042
Study site
Naples, 80131
Study site
Palermo, 90127
Study site
Potenza, 85100
Study site
Reggio Emilia, 42100
Study site
Roma, 00161
Austria5 sites
Study site
Graz, A-8020
Study site
Graz, A-8036
Study site
Innsbruck, A-6020
Study site
Vienna, A-1090
Study site
Vienna, A-1100
Denmark5 sites
Study site
Frederiksberg, DK-2000
Study site
Holstebro, DK-7500
Study site
Kolding, DK-6000
Study site
Randers, DK-8900
Study site
Silkeborg, DK-8600
Netherlands5 sites
Study site
Den Helder, 1782 GZ
Study site
Enschede, 7511 JX
Study site
Flushing, 4382 EE
Study site
Leeuwarden, 8934 AD
Study site
Zwolle, 8011 JW
Norway5 sites
Study site
Haugesund, 5504
Study site
Levanger, 7600
Study site
Lillehammer, N-2609
Study site
Tromsø, 9038
Study site
Trondheim, N-7006
Finland4 sites
Study site
Helsinki, 00280
Study site
Hyvinkää, 05800
Study site
Kouvola, 45100
Study site
Turku, 20521
Sweden4 sites
Study site
Eskilstuna, SE-631 88
Study site
Örebro, SE- 701 85
Study site
Östersund, SE-831 83
Study site
Vaxjo, SE-351 85
Switzerland3 sites
Study site
Bern, 3010
Study site
Zurich, 8063
Study site
Zurich, 8091
About this study
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)
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)
- Conditions
- Ankylosing Spondylitis
- Being tested
- adalimumab (Humira)
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumab (Humira)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
ASAS 20/40/50/70
ASAS 5/6
BASDAI score
Secondary outcomes (3)
Adverse events
Laboratory data
Vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Beverly Paperiello, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478660
- Sponsor's protocol ID
- M05-760
- Acronym
- RHAPSODY
- Status last verified
- Oct 2007
- First submitted
- 23 May 2007
- Last updated
- 10 Oct 2007
- Results posted
- No
Publications
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.
PubMed 20553600Rudwaleit 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.
PubMed 20230622Rudwaleit 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.
PubMed 19273449Rudwaleit 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.
PubMed 18662932
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00478660
- Acronym / sponsor ID
- RHAPSODY / M05-760
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- First posted
- 25 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumab (Humira) | Drug | – |
Primary outcome
ASAS 20/40/50/70
ASAS 5/6
BASDAI score
3 secondary outcomes
Adverse events
Laboratory data
Vital signs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2007.
- Derived from this study: PubMed 20553600Rudwaleit 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.
- Derived from this study: PubMed 20230622Rudwaleit 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.
- Derived from this study: PubMed 19273449Rudwaleit 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.
- Derived from this study: PubMed 18662932Rudwaleit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly Paperiello study director
Abbott
205 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab (Humira) in people with Ankylosing Spondylitis, run by Abbott at 205 sites in 15 countries.
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 10 inclusion and 17 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 10 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 205 sites in Germany, France, Spain, United Kingdom, Greece and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
ASAS 20/40/50/70. The study lists 3 primary outcomes in all. 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 NCT00478660, which also lists 4 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 10 Oct 2007.