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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)

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00478660
Collaborator
(none)
1,250
Enrollment
205
Locations
6.1
Patients Per Site

Study Details

Study Description

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
  • Drug: adalimumab (Humira)
 Phase 3

Study Design

Study Type:
Interventional
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 :
Feb 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Graz Austria A-8020
2 Graz Austria A-8036
3 Innsbruck Austria A-6020
4 Wien Austria A-1090
5 Wien Austria A-1100
6 Aalst Belgium 9300
7 Belsele Belgium B-9111
8 Brugge Belgium 8000
9 Charleroi Belgium 6000
10 Erembodegem Belgium 9320
11 Genk Belgium 3600
12 Gent Belgium B-9000
13 Hasselt Belgium B-3500
14 Oostende Belgium 8400
15 Frederiksberg Denmark DK-2000
16 Holstebro Denmark DK-7500
17 Kolding Denmark DK-6000
18 Randers Denmark DK-8900
19 Silkeborg Denmark DK-8600
20 Helsinki Finland 00280
21 Hyvinkaa Finland 05800
22 Kouvola Finland 45100
23 Turku Finland 20521
24 Aix En Provence France 13616
25 Aix Les Bains France 73106
26 Amiens Cedex France 80054
27 Angers Cedex 1 France 49033
28 Belfort France 90016
29 Berck Cedex France 62608
30 Besancon France 25030
31 Bordeaux Cedex France 33076
32 Boulogne Billancourt France 92100
33 Brest Cedex France 29609
34 Caen-Cedex France 14033
35 Cahors France 46005
36 Clermont-ferrand France 63003
37 Corbeil Essonnes France 91108
38 Creteil France 94010
39 Dijon Cedex France 21033
40 Grenoble France 38043
41 Le Kremlin Bicetre France 94275
42 Le Mans France 72037
43 Levin Cedex France 62806
44 Libourne France 33505
45 Lille Cedex France 59037
46 Limoges France 87042
47 Lomme France 59462
48 Lyon Cedex 03 France 69437
49 Lyon Cedex 07 France 69365
50 Lyon France 69310
51 Marseille Cedex 5 France 13385
52 Marseille Cedex France 13285
53 Montivilliers France 76290
54 Montpellier Cedex 5 France 34295
55 Mulhouse Cedex France 68070
56 NANTES Cedex France 44035
57 Nice France 06202
58 Orleans Cedex 01 France 45032
59 Paris Cedex 10 France 75475
60 Paris Cedex 13 France 75651
61 Paris France 75012
62 Paris France 75014
63 Pau Cedex France 64046
64 Poitiers France 86021
65 Reims France 51092
66 Rennes Cedex France 35203
67 Saint Brieuc Cedex 1 France 22023
68 Saint Etienne France 42055
69 Strasbourg France 67098
70 Toulouse Cedex 9 France 31059
71 Tours Cedex France 37044
72 Valenciennes France 59322
73 Vandoeuvre les Nancy France 54511
74 Bad Bentheim Germany D-48455
75 Bad Bramstedt Germany 24576
76 Bad Nauheim Germany D-61231
77 Bad Germany 83043
78 Berlin Germany 10117
79 Berlin Germany 12200
80 Berlin Germany 13055
81 Berlin Germany 13125
82 Berlin Germany D-14109
83 Chemnitz Germany D-09130
84 Cottbus Germany 03048
85 Damp Germany 24349
86 Dresden Germany 01307
87 Dresden Germany D-01067
88 Duisburg Germany 47055
89 Düsseldorf Germany 40225
90 Erfurt Germany 99096
91 Erlangen Germany 91054
92 Frankfurt Germany 60528
93 Freiburg Germany 79106
94 Goslar Germany 38640
95 Göttingen Germany 37075
96 Hamburg Germany 21075
97 Hamburg Germany 22147
98 Hamburg Germany D-22081
99 Hannover Germany 30625
100 Heidelberg Germany D-69115
101 Herne Germany 44652
102 Hildesheim Germany D-31134
103 Hofheim Germany D-65719
104 Hoyerswerda Germany 02977
105 Jena Germany D-07747
106 Kiel Germany 24116
107 Köln Germany 50924
108 Leipzig Germany 04103
109 München Germany 80639
110 München Germany 81541
111 Neubrandenburg Germany 17033
112 Osnabrück Germany D-49074
113 Planegg Germany D-82152
114 Ratingen Germany D-40882
115 Regensburg Germany 93042
116 Rostock Germany 18059
117 Sendenhorst Germany 48324
118 Stuttgart Germany 70178
119 Stuttgart Germany 70372
120 Tübingen Germany 72076
121 Villingen Germany 78054
122 Vogelsang/Gommern Germany 39245
123 Würzburg Germany D-97070
124 Zerbst Germany 39261
125 Zeven Germany 27404
126 Athens Greece 11521
127 Athens Greece 11527
128 Athens Greece
129 Heraklion Greece
130 Ioannina Greece 45500
131 Larisa Greece 41110
132 Patras Greece 26500
133 Thessaloniki Greece 54636
134 Thessaloniki Greece 54642
135 Thessaloniki Greece 55134
136 Thessaloniki Greece 56403
137 Cork Ireland
138 Dublin Ireland 7
139 Firenze Italy 50139
140 Monserrato Italy 09042
141 Napoli Italy 80131
142 Palermo Italy 90127
143 Potenza Italy 85100
144 Reggio Emilia Italy 42100
145 Roma Italy 00161
146 Den Helder Netherlands 1782 GZ
147 Enschede Netherlands 7511 JX
148 Leeuwarden Netherlands 8934 AD
149 Vlissingen Netherlands 4382 EE
150 Zwolle Netherlands 8011 JW
151 Haugesund Norway 5504
152 Levanger Norway 7600
153 Lillehammer Norway N-2609
154 Tromsø Norway 9038
155 Trondheim Norway N-7006
156 A Coruña Spain 15006
157 Alicante Spain 03203
158 Asturias Spain 33012
159 Barakaldo Spain 48903
160 Barcelona Spain 08003
161 Barcelona Spain 08035
162 Barcelona Spain 08208
163 Barcelona Spain 08221
164 Barcelona Spain 08304
165 Burgos Spain 09005
166 Las Palmas de Gran Canaria Spain 35016
167 Las Palmas de Gran Canaria Spain 35020
168 Madrid Spain 28007
169 Madrid Spain 28034
170 Madrid Spain 28035
171 Madrid Spain 28041
172 Madrid Spain 28880
173 Pamplona Spain 31008
174 Valencia Spain 46017
175 Valladolid Spain 47010
176 Vitoria-Gasteiz Spain 01009
177 Vizcaya Spain 48013
178 Zaragoza Spain 50009
179 Eskilstuna Sweden SE-631 88
180 Växjö Sweden SE-351 85
181 Örebro Sweden SE- 701 85
182 Östersund Sweden SE-831 83
183 Bern Switzerland 3010
184 Zürich Switzerland 8063
185 Zürich Switzerland 8091
186 Aberdeen United Kingdom AB25 2ZN
187 Avon United Kingdom BA1 1RL
188 Birmingham United Kingdom B29 6JD
189 Cambridge United Kingdom CB2 2QQ
190 Greater Manchester United Kingdom M6 8HD
191 Harrow United Kingdom HA1 3UJ
192 Huddersfield United Kingdom HD3 3EA
193 Leeds United Kingdom LS7 4SA
194 Liverpool United Kingdom L9 7AL
195 London United Kingdom SE1 9RT
196 London United Kingdom SE5 9PJ
197 London United Kingdom SW10 9NH
198 Merseyside United Kingdom CH49 5PE
199 Newcastle upon Tyne United Kingdom NE7 7DN
200 Oxford United Kingdom OX3 7LD
201 Portsmouth United Kingdom PO6 3LY
202 Sheffield United Kingdom S10 2JF
203 Southampton United Kingdom SO16 6YD
204 Truro United Kingdom TR1 3LJ
205 Wigan United Kingdom WN6 9EP

Sponsors and Collaborators

  • Abbott

Investigators

  • Study Director: Beverly Paperiello, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00478660
Other Study ID Numbers:
  • M05-760
First Posted:
May 25, 2007
Last Update Posted:
Oct 10, 2007
Last Verified:
Oct 1, 2007
Additional relevant MeSH terms:
Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Adalimumab

Study Results

No Results Posted as of Oct 10, 2007