Phase
Condition
Connective Tissue Diseases
Ankylosing Spondylitis
Treatment
Golimumab
Placebo
Clinical Study ID
Ages 18-45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Is not of reproductive potential, or is of reproductive potential and agrees to avoidbecoming pregnant or impregnating a partner while receiving trial medication or within 6 months after the last dose of trial medication
- Has chronic back pain of ≥3 months duration by history
- Has physician-diagnosed active non-radiographic axial spondyloarthritis (nr-axSpA)with disease duration <= 5 years
- Meets one of the following criteria:
- Has active inflammation on magnetic resonance imaging (MRI) highly suggestive ofsacroiliitis associated with spondyloarthropathy and 1 or more of the followingspondyloarthritis (SpA) characteristics:
- Inflammatory back pain
- Arthritis (physician-diagnosed)
- Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness atexamination of the site of the insertion of the Achilles tendon or plantarfascia)
- Dactylitis (physician-diagnosed)
- Psoriasis (physician-diagnosed)
- History of physician-diagnosed inflammatory bowel disease (IBD)
- History of uveitis confirmed by an ophthalmologist
- Good response to nonsteroidal anti-inflammatory drugs (NSAID)
- Family history of SpA (presence of ankylosing spondylitis, psoriasis, acuteuveitis, reactive arthritis, or IBD)
- Elevated C-reactive protein (CRP)
- Human leukocyte antigen B27 (HLA-B27)+ gene OR
- Has a HLA-B27+ gene and 2 or more of the following SpA characteristics:
- Inflammatory back pain
- Arthritis (physician-diagnosed)
- Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness atexamination of the site of the insertion of the Achilles tendon or plantarfascia)
- Dactylitis (physician-diagnosed)
- Psoriasis (physician-diagnosed)
- History of physician-diagnosed inflammatory bowel disease (IBD)
- History of uveitis confirmed by an ophthalmologist
- Good response to nonsteroidal anti-inflammatory drugs (NSAID)
- Family history of SpA (presence of ankylosing spondylitis, psoriasis, acuteuveitis, reactive arthritis, or IBD)
- Elevated C-reactive protein (CRP)
- Has elevated CRP at Screening or evidence of active inflammation in the sacroiliacjoints on MRI
- Has an Ankylosing Spondylitis Disease Activity Score (ASDAS) >= 2.1 at Screening
- Shows high disease activity at Screening and Baseline of both a Total Back Pain scoreof ≥4 and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4
- Has an acceptable history of NSAID use
- Has no history of untreated latent or active tuberculosis (TB) prior to Screening
- Has had no recent close contact with a person with active TB or, if there has beensuch contact, will undergo additional evaluations and receive appropriate treatmentfor latent TB
- Agrees to undergo screening for hepatitis B virus (HBV) and demonstrates negativeresults for hepatitis B surface antigen (HBsAg) and HBV deoxyribonucleic acid (DNA)
Exclusion
Exclusion Criteria:
- Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 onconventional x-rays
- Is a nursing or pregnant female, or intends to become pregnant within 6 months afterreceiving trial medication
- Intends to donate eggs (female participants) or sperm (male participants) whilereceiving trial medication or within 6 months after trial medication
- Has any clinically significant condition or situation that would interfere with thetrial evaluations or participation in the trial
- Has ever received any cytotoxic drugs, including chlorambucil, cyclophosphamide,nitrogen mustard, or other alkylating agents
- Has received any treatment listed below more recently than the indicated off-drugperiod prior to Screening
- • Disease-modifying anti-rheumatic drugs (30 days off drug)
- • Live vaccinations (3 months off drug)
- • Investigational medications (30 days or 5 half-lives off drug, whichever islonger)
- • Bacille Calmette-Guerin (BCG) vaccination (12 months off drug)
- Has any systemic inflammatory condition, including psoriatic arthritis, active Lymedisease, systemic lupus erythematosus, infectious arthritis, vasculitis, parvovirusinfection, rheumatoid arthritis, active uveitis, or active IBD
- Has a history of latent or active granulomatous infection prior to Screening
- Had a nontuberculous mycobacterial infection or opportunistic infection within 6months prior to Screening
- Has a history of an infected joint prosthesis, or has received antibiotics for asuspected infection of a joint prosthesis, if that prosthesis has not been removed orreplaced
- Had a serious infection, has been hospitalized for an infection, or has been treatedwith IV antibiotics for an infection within 2 months prior to Baseline
- Had a history of, or ongoing, chronic or recurrent infectious disease
- Is known to be infected with human immunodeficiency virus (HIV) or seropositive forhepatitis C virus (HCV)
- Has had a chest x-ray within 2 months prior to Screening that shows an abnormalitysuggestive of a current active infection or malignancy
- Has a history of lymphoproliferative disease
- Has had a malignancy within 5 years before screening (exceptions are squamous andbasal cell carcinomas of the skin and carcinoma in situ of cervix that has beensurgically cured)
- Has a history of known demyelinating diseases such as multiple sclerosis or opticneuritis
- Has a history of or concurrent congestive heart failure of any grade
- Has a transplanted organ (with the exception of a corneal transplant performed >= 3months prior to baseline)
- Has current signs or symptoms of significant medical illness which could interferewith the trial, or require treatment that might interfere with the trial
- Is a user of recreational or illicit drugs or has or had a substance abuse (drug oralcohol) problem within the previous 2 years
Study Design
Connect with a study center
MHAT Burgas ( Site 0202)
Burgas,
BulgariaSite Not Available
MHAT Central Onco Hospital ( Site 0200)
Plovdiv,
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment - Ruse ( Site 0201)
Ruse,
BulgariaSite Not Available
Medical Center - 1- Sevlievo EOOD ( Site 0203)
Sevlievo,
BulgariaSite Not Available
MHAT Saint Ivan Rilski ( Site 0205)
Sofia,
BulgariaSite Not Available
New Rehabilitation Center ( Site 0197)
Stara Zagora,
BulgariaSite Not Available
FN Brno ( Site 0005)
Brno, 625 00
CzechiaSite Not Available
Revmatologie s.r.o. ( Site 0009)
Brno, 638 00
CzechiaSite Not Available
CCBR Ostrava s.r.o. ( Site 0001)
Ostrava, 702 00
CzechiaSite Not Available
Artroscan s.r.o. ( Site 0007)
Ostrava - Trebovice, Prague 6
CzechiaSite Not Available
Artroscan s.r.o. ( Site 0007)
Ostrava-Trebovice, 722 00
CzechiaSite Not Available
CCR Czech a.s. ( Site 0003)
Pardubice, 530 02
CzechiaSite Not Available
CCR Prague s.r.o ( Site 0004)
Praha, 130 00
CzechiaSite Not Available
Fakultni nemocnice v Motole ( Site 0127)
Praha, 150 06
CzechiaSite Not Available
Medical Plus s.r.o ( Site 0010)
Uherske Hradiste, 686 01
CzechiaSite Not Available
PV - Medical s.r.o. ( Site 0006)
Zlin, 760 01
CzechiaSite Not Available
North Estonia Medical Centre Foundation ( Site 0208)
Tallinn,
EstoniaSite Not Available
Meditrials Clinical Research Center ( Site 0206)
Tartu,
EstoniaSite Not Available
Universitaetsklinik der Charite Berlin ( Site 0023)
Berlin, 12203
GermanySite Not Available
Rheumazentrum Ruhrgebiet ( Site 0021)
Herne, 44649
GermanySite Not Available
U. klinikum Koeln AOER ( Site 0025)
Koeln, 50937
GermanySite Not Available
Herbert Kellner Innere Medizin Rheumatologie und Gastroenterologie ( Site 0022)
Muenchen, 80639
GermanySite Not Available
Klinikum der Universitaet Muenchen - LMU ( Site 0026)
Muenchen, 80336
GermanySite Not Available
St Vincent's University Hospital ( Site 0101)
Dublin,
IrelandSite Not Available
Artrita Klinika ( Site 0215)
Riga,
LatviaSite Not Available
VAKK Dr. Kildos klinika ( Site 0217)
Kaunas,
LithuaniaSite Not Available
Klaipedos universitetine ligonine ( Site 0219)
Klaipeda,
LithuaniaSite Not Available
Vilniaus universiteto ligonines Santariskiu klinikos ( Site 0218)
Vilnius,
LithuaniaSite Not Available
Antonius Ziekenhuis Sneek ( Site 0043)
Sneek, Friesland 8601 ZK
NetherlandsSite Not Available
Vrij Universiteit Medisch Centrum ( Site 0044)
Amsterdam, 1081 HV
NetherlandsSite Not Available
Leids Universitair Medisch Centrum ( Site 0041)
Leiden, 2333 ZA
NetherlandsSite Not Available
Maasstad Ziekenhuis ( Site 0042)
Rotterdam, 3079 DZ
NetherlandsSite Not Available
Centrum Medyczne Pratia Katowice ( Site 0059)
Katowice, Slaskie 40-081
PolandSite Not Available
Prywatna Praktyka Lekarska, Dr. med. Pawel Hrycaj ( Site 0060)
Poznan, Wielkopolskie 61-397
PolandSite Not Available
NZOZ Osteo-Medic s.c. A. Racewicz, R. Supronik ( Site 0058)
Bialystok, 15-351
PolandSite Not Available
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 0153)
Bydgoszcz, 85-168
PolandSite Not Available
Centrum Kliniczno-Badawcze ( Site 0152)
Elblag, 82-300
PolandSite Not Available
Krakow Medical Centre ( Site 0052)
Krakow, 31-501
PolandSite Not Available
NZOZ Reumed ( Site 0051)
Lublin, 20-582
PolandSite Not Available
Pomorskie Cent. Reumatologiczne IM.Dr. Titz-Kosko W Sopocie Sp. Z.o.o. ( Site 0057)
Sopot, 81-759
PolandSite Not Available
Lubelskie Centrum Diagnostyczne ( Site 0053)
Swidnik, 21-040
PolandSite Not Available
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych ( Site 0151)
Torun, 87-100
PolandSite Not Available
Reumatika ( Site 0055)
Warszawa, 02-691
PolandSite Not Available
Spitalul Judetean de Urgenta Baia Mare Dr Constantin Opris ( Site 0181)
Baia Mare,
RomaniaSite Not Available
Centrul Medical de Diagnostic si Tratament Ambulator Neomed ( Site 0177)
Brasov, 500283
RomaniaSite Not Available
Colentina Clinical Hospital ( Site 0231)
Bucarest, 020125
RomaniaSite Not Available
Clinical Hospital Ioan Cantacuzino ( Site 0184)
Bucaresti, 020475
RomaniaSite Not Available
Spitalul Clinic Sfanta Maria ( Site 0182)
Bucharest, 011172
RomaniaSite Not Available
SC Duo Medical SRL ( Site 0183)
Bucuresti, 010584
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Cluj-Napoca ( Site 0176)
Cluj Napoca, 400006
RomaniaSite Not Available
RKMed Center ( Site 0180)
Iasi, 700127
RomaniaSite Not Available
S.C.Pelican Impex S.R.L ( Site 0232)
Oradea, 410450
RomaniaSite Not Available
Covamed Serv SRL ( Site 0178)
Sfantu Gheorghe, 520052
RomaniaSite Not Available
Cabinet Medical Medicina Interna Dr. Triff Carina ( Site 0179)
Timisoara, 300766
RomaniaSite Not Available
GUZ Regional Clinical Hospital ( Site 0076)
Saratov, Oktyabrskiy Region 410053
Russian FederationSite Not Available
Rheumatology Research Institute n.a. V.A.Nasonova of RAMS ( Site 0061)
Moscow, 115522
Russian FederationSite Not Available
SBHI Leningrad Regional Clinical Hospital ( Site 0065)
Saint Petersburg, 194291
Russian FederationSite Not Available
SPb SBHI Clinical Rheumatological Hospital 25 ( Site 0077)
Saint Petersburg, 190068
Russian FederationSite Not Available
LLC Sanavita ( Site 0074)
Saint-Petersburg, 195257
Russian FederationSite Not Available
Tolyatti City Clinical Hospital 5 ( Site 0069)
Tolyatti, 445039
Russian FederationSite Not Available
Yaroslavl Clinical Hospital for Emergency Care na. NV. Solovyev. ( Site 0075)
Yaroslavl, 150003
Russian FederationSite Not Available
Hospital de Basurto ( Site 0082)
Bilbao, 48013
SpainSite Not Available
Hospital Universitario Reina Sofia ( Site 0081)
Cordoba, 14004
SpainSite Not Available
Hospital Universitario La Paz ( Site 0083)
Madrid, 28046
SpainSite Not Available
Hospital Clinico Universitario Virgen de la Arrixaca ( Site 0085)
Murcia, 30120
SpainSite Not Available
Akdeniz Universitesi Tip Fakultesi Romatoloji Departmani ( Site 0094)
Antalya, Ankara 07070
TurkeySite Not Available
Ankara Numune Egitim Arastirma Hastanesi ( Site 0092)
Ankara, 06100
TurkeySite Not Available
Ankara Universitesi Tıp Fakultesi ( Site 0093)
Ankara, 06230
TurkeySite Not Available
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0091)
Ankara, 06100
TurkeySite Not Available
Pamukkale Unv. Tip Fak. ( Site 0097)
Denizli, 20070
TurkeySite Not Available
Eskisehir Osmangazi Universitesi Saglık Uygulama Hastanesi ( Site 0099)
Eskisehir,
TurkeySite Not Available
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0098)
Istanbul, 34899
TurkeySite Not Available
Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari ( Site 0096)
Kocaeli, 41380
TurkeySite Not Available
Cherkassy Regional hospital of Cherkassy Regional council ( Site 0221)
Cherkassy, 18009
UkraineSite Not Available
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222)
Dnipro,
UkraineSite Not Available
MI Dnipropetrovsk Regional Clinical Hosp n a I.I. Mechnikov ( Site 0222)
Dnipropetrovs k,
UkraineSite Not Available
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222)
Dnipropetrovsk, 49005
UkraineSite Not Available
Regional Clinical Hospital. ( Site 0270)
Ivano-Frankivsk,
UkraineSite Not Available
ME of Health Care Kharkiv City Clinical Hospital #8 ( Site 0262)
Kharkiv, 61176
UkraineSite Not Available
SI National Institute of therapy n.a L.T. Maloi NAMS of Ukraine ( Site 0261)
Kharkiv, 61039
UkraineSite Not Available
Khmelnytskyy regional hospital ( Site 0228)
Khmelnytskyy,
UkraineSite Not Available
Clinic of Modern Rheumatology ( Site 0265)
Kyiv, 04070
UkraineSite Not Available
Kyivska miska klinichna likarnia N3 ( Site 0266)
Kyiv, 02125
UkraineSite Not Available
M. D. Strazhesko Institute of Cardiology. ( Site 0264)
Kyiv, 03680
UkraineSite Not Available
Medical Center Ibn Sina ( Site 0268)
Kyiv, 04050
UkraineSite Not Available
Communal City Clinical Hospital #4 ( Site 0230)
Lviv, 79011
UkraineSite Not Available
MI Odesa Regional Clinical Hospital ( Site 0226)
Odesa, 65117
UkraineSite Not Available
M.V.Sklifosovskyi Poltava Regional Clinical Hospital ( Site 0224)
Poltava, 36011
UkraineSite Not Available
Vinnitsa Regional Clinical Hospital n.a. Pirogov ( Site 0225)
Vinnutsya, 21018
UkraineSite Not Available
SRI of Invalid Rehabilitation of Vinnytsia M.I.Pyrogov ( Site 0263)
Vinnytsia, 21000
UkraineSite Not Available
Zaporizhzha Regional Clinical Hospital ( Site 0223)
Zaporizhzhya, 69600
UkraineSite Not Available
Whipps Cross University Hospital ( Site 0104)
London,
United KingdomSite Not Available

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