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)

Last updated: October 4, 2007
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Ankylosing Spondylitis

Arthritis And Arthritic Pain

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT00478660
M05-760
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able and willing to give written informed consent and to comply with the requirementsof 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 currentnational guidelines for treatment of AS with TNF inhibitors (if applicable) includinga minimum of failing at least one NSAID. National guidelines (if applicable) must befollowed if the guidelines are more strict regarding the use of TNF inhibitors for thetreatment of AS

  • Use of reliable method of contraception, e.g., IUDs, condoms, or hormone (oral,implantable, or injectable) contraceptives by all female subjects of childbearingpotential. Subject must follow the manufacture's recommendations of contraceptionprior to the administration of study drug and through 150 days following the lastadministration of adalimumab

  • Able and willing to self-administer sc injections or have available a suitable personto administer sc injections

  • A negative pregnancy test (serum HCG) for women of childbearing potential prior tostart 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 theadministration of adalimumab

Exclusion

Exclusion Criteria:

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

  • Treatment within the last six weeks with infliximab or within the last three weekswith 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 followingconditions:

  • Dose is >10 mg/d systemically within the 28 days before screening

  • Intraarticular injections or infiltrations of peripheral joints and tendonswithin 28 days before or at screening

  • Intraarticular injections of sacroiliac joints without therapeutic response <=14days before screening

  • Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease,congestive heart failure (NYHA III-IV), recent stroke (within three months), chronicleg ulcer and any other condition (e.g., indwelling urinary catheter) which, in theopinion of the investigator, would put the subject at risk by participation in thestudy

  • History of cancer or malignant lymphoproliferative disease other than a successfullytreated non-metastatic cutaneous squamous cell or basal cell carcinoma and/orlocalized carcinoma in situ of the cervix

  • History of positive serology for hepatitis B indicating active infection or history ofpositive serology for hepatitis C

  • History of positive HIV status

  • Persistent or recurrent infections or severe infections requiring hospitalization ortreatment with iv antibiotics within 30 days, or oral antibiotics within 14 days priorto enrollment

  • Previous diagnosis or signs highly indicative of central nervous system demyelinatingdiseases (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 Design

Total Participants: 1250
Study Start date:
February 01, 2006
Estimated Completion Date:

Connect with a study center

  • Graz, A-8020
    Austria

    Site Not Available

  • Innsbruck, A-6020
    Austria

    Site Not Available

  • Wien, A-1090
    Austria

    Site Not Available

  • Aalst, 9300
    Belgium

    Site Not Available

  • Belsele, B-9111
    Belgium

    Site Not Available

  • Brugge, 8000
    Belgium

    Site Not Available

  • Charleroi, 6000
    Belgium

    Site Not Available

  • Erembodegem, 9320
    Belgium

    Site Not Available

  • Genk, 3600
    Belgium

    Site Not Available

  • Gent, B-9000
    Belgium

    Site Not Available

  • Hasselt, B-3500
    Belgium

    Site Not Available

  • Oostende, 8400
    Belgium

    Site Not Available

  • Frederiksberg, DK-2000
    Denmark

    Site Not Available

  • Holstebro, DK-7500
    Denmark

    Site Not Available

  • Kolding, DK-6000
    Denmark

    Site Not Available

  • Randers, DK-8900
    Denmark

    Site Not Available

  • Silkeborg, DK-8600
    Denmark

    Site Not Available

  • Helsinki, 00280
    Finland

    Site Not Available

  • Hyvinkaa, 05800
    Finland

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  • Kouvola, 45100
    Finland

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  • Turku, 20521
    Finland

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  • Aix En Provence, 13616
    France

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  • Aix Les Bains, 73106
    France

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  • Amiens Cedex, 80054
    France

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  • Angers Cedex 1, 49033
    France

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  • Belfort, 90016
    France

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  • Berck Cedex, 62608
    France

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  • Besancon, 25030
    France

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  • Bordeaux Cedex, 33076
    France

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  • Boulogne Billancourt, 92100
    France

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  • Brest Cedex, 29609
    France

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  • Caen-Cedex, 14033
    France

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  • Cahors, 46005
    France

    Site Not Available

  • Clermont-ferrand, 63003
    France

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  • Corbeil Essonnes, 91108
    France

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  • Creteil, 94010
    France

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  • Dijon Cedex, 21033
    France

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  • Grenoble, 38043
    France

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  • Le Kremlin Bicetre, 94275
    France

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  • Le Mans, 72037
    France

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  • Levin Cedex, 62806
    France

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  • Libourne, 33505
    France

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  • Lille Cedex, 59037
    France

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  • Limoges, 87042
    France

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  • Lomme, 59462
    France

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  • Lyon, 69310
    France

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  • Lyon Cedex 03, 69437
    France

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  • Lyon Cedex 07, 69365
    France

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  • Marseille Cedex, 13285
    France

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  • Marseille Cedex 5, 13385
    France

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  • Montivilliers, 76290
    France

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  • Montpellier Cedex 5, 34295
    France

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  • Mulhouse Cedex, 68070
    France

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  • NANTES Cedex, 44035
    France

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  • Nice, 06202
    France

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  • Orleans Cedex 01, 45032
    France

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  • Paris, 75012
    France

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  • Paris Cedex 10, 75475
    France

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  • Paris Cedex 13, 75651
    France

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  • Pau Cedex, 64046
    France

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  • Poitiers, 86021
    France

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  • Reims, 51092
    France

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  • Rennes Cedex, 35203
    France

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  • Saint Brieuc Cedex 1, 22023
    France

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  • Saint Etienne, 42055
    France

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  • Strasbourg, 67098
    France

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  • Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Tours Cedex, 37044
    France

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  • Valenciennes, 59322
    France

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  • Vandoeuvre les Nancy, 54511
    France

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  • Bad, 83043
    Germany

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  • Bad Bentheim, D-48455
    Germany

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  • Bad Bramstedt, 24576
    Germany

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  • Bad Nauheim, D-61231
    Germany

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  • Berlin, D-14109
    Germany

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  • Chemnitz, D-09130
    Germany

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  • Cottbus, 03048
    Germany

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  • Damp, 24349
    Germany

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  • Dresden, 01307
    Germany

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  • Duisburg, 47055
    Germany

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    Düsseldorf, 40225
    Germany

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  • Düsseldorf, 40225
    Germany

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  • Erfurt, 99096
    Germany

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  • Erlangen, 91054
    Germany

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  • Frankfurt, 60528
    Germany

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  • Freiburg, 79106
    Germany

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  • Goslar, 38640
    Germany

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    Göttingen, 37075
    Germany

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  • Göttingen, 37075
    Germany

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  • Hamburg, D-22081
    Germany

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  • Hannover, 30625
    Germany

    Site Not Available

  • Heidelberg, D-69115
    Germany

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  • Herne, 44652
    Germany

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  • Hildesheim, D-31134
    Germany

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  • Hofheim, D-65719
    Germany

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  • Hoyerswerda, 02977
    Germany

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  • Jena, D-07747
    Germany

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  • Kiel, 24116
    Germany

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    Köln, 50924
    Germany

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  • Köln, 50924
    Germany

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  • Leipzig, 04103
    Germany

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  • empty

    München, 81541
    Germany

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  • München, 80639
    Germany

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  • Neubrandenburg, 17033
    Germany

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  • empty

    Osnabrück, D-49074
    Germany

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  • Osnabrück, D-49074
    Germany

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  • Planegg, D-82152
    Germany

    Site Not Available

  • Ratingen, D-40882
    Germany

    Site Not Available

  • Regensburg, 93042
    Germany

    Site Not Available

  • Rostock, 18059
    Germany

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  • Sendenhorst, 48324
    Germany

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  • Stuttgart, 70372
    Germany

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    Tübingen, 72076
    Germany

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  • Tübingen, 72076
    Germany

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  • Villingen, 78054
    Germany

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  • Vogelsang/Gommern, 39245
    Germany

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    Würzburg, D-97070
    Germany

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  • Würzburg, D-97070
    Germany

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  • Zerbst, 39261
    Germany

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  • Zeven, 27404
    Germany

    Site Not Available

  • Athens, 11527
    Greece

    Site Not Available

  • Heraklion,
    Greece

    Site Not Available

  • Ioannina, 45500
    Greece

    Site Not Available

  • Larisa, 41110
    Greece

    Site Not Available

  • Patras, 26500
    Greece

    Site Not Available

  • Thessaloniki, 54636
    Greece

    Site Not Available

  • Cork,
    Ireland

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  • Dublin, 7
    Ireland

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  • Firenze, 50139
    Italy

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  • Monserrato, 09042
    Italy

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  • Napoli, 80131
    Italy

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  • Palermo, 90127
    Italy

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  • Potenza, 85100
    Italy

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  • Reggio Emilia, 42100
    Italy

    Site Not Available

  • Roma, 00161
    Italy

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  • Den Helder, 1782 GZ
    Netherlands

    Site Not Available

  • Enschede, 7511 JX
    Netherlands

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  • Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

  • Vlissingen, 4382 EE
    Netherlands

    Site Not Available

  • Zwolle, 8011 JW
    Netherlands

    Site Not Available

  • Haugesund, 5504
    Norway

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  • Levanger, 7600
    Norway

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  • Lillehammer, N-2609
    Norway

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  • empty

    Tromsø, 9038
    Norway

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  • Tromsø, 9038
    Norway

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  • Trondheim, N-7006
    Norway

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  • empty

    A Coruña, 15006
    Spain

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  • A Coruña, 15006
    Spain

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  • Alicante, 03203
    Spain

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  • Asturias, 33012
    Spain

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  • Barakaldo, 48903
    Spain

    Site Not Available

  • Barcelona, 08304
    Spain

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  • Burgos, 09005
    Spain

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  • Las Palmas de Gran Canaria, 35016
    Spain

    Site Not Available

  • Madrid, 28880
    Spain

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  • Pamplona, 31008
    Spain

    Site Not Available

  • Valencia, 46017
    Spain

    Site Not Available

  • Valladolid, 47010
    Spain

    Site Not Available

  • Vitoria-Gasteiz, 01009
    Spain

    Site Not Available

  • Vizcaya, 48013
    Spain

    Site Not Available

  • Zaragoza, 50009
    Spain

    Site Not Available

  • Eskilstuna, SE-631 88
    Sweden

    Site Not Available

  • empty

    Växjö, SE-351 85
    Sweden

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  • Växjö, SE-351 85
    Sweden

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  • empty

    Örebro, SE- 701 85
    Sweden

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  • empty

    Östersund, SE-831 83
    Sweden

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  • Örebro, SE- 701 85
    Sweden

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  • Östersund, SE-831 83
    Sweden

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  • Bern, 3010
    Switzerland

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  • empty

    Zürich, 8063
    Switzerland

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  • Zürich, 8063
    Switzerland

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  • Aberdeen, AB25 2ZN
    United Kingdom

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  • Avon, BA1 1RL
    United Kingdom

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  • Birmingham, B29 6JD
    United Kingdom

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  • Cambridge, CB2 2QQ
    United Kingdom

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  • Greater Manchester, M6 8HD
    United Kingdom

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  • Harrow, HA1 3UJ
    United Kingdom

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  • Huddersfield, HD3 3EA
    United Kingdom

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  • Leeds, LS7 4SA
    United Kingdom

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  • Liverpool, L9 7AL
    United Kingdom

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  • London, SE1 9RT
    United Kingdom

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  • Merseyside, CH49 5PE
    United Kingdom

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  • Newcastle upon Tyne, NE7 7DN
    United Kingdom

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  • Oxford, OX3 7LD
    United Kingdom

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  • Portsmouth, PO6 3LY
    United Kingdom

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  • Sheffield, S10 2JF
    United Kingdom

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  • Southampton, SO16 6YD
    United Kingdom

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  • Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Wigan, WN6 9EP
    United Kingdom

    Site Not Available

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