Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)

Last updated: July 25, 2023
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

4

Condition

Connective Tissue Diseases

Ankylosing Spondylitis

Treatment

Golimumab

Placebo

Clinical Study ID

NCT03253796
8259-038
2015-004020-65
MK-8259-038
  • Ages 18-45
  • All Genders

Study Summary

The purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.

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:
  1. 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
  1. 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

Total Participants: 323
Treatment Group(s): 2
Primary Treatment: Golimumab
Phase: 4
Study Start date:
November 07, 2017
Estimated Completion Date:
March 17, 2021

Connect with a study center

  • MHAT Burgas ( Site 0202)

    Burgas,
    Bulgaria

    Site Not Available

  • MHAT Central Onco Hospital ( Site 0200)

    Plovdiv,
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment - Ruse ( Site 0201)

    Ruse,
    Bulgaria

    Site Not Available

  • Medical Center - 1- Sevlievo EOOD ( Site 0203)

    Sevlievo,
    Bulgaria

    Site Not Available

  • MHAT Saint Ivan Rilski ( Site 0205)

    Sofia,
    Bulgaria

    Site Not Available

  • New Rehabilitation Center ( Site 0197)

    Stara Zagora,
    Bulgaria

    Site Not Available

  • FN Brno ( Site 0005)

    Brno, 625 00
    Czechia

    Site Not Available

  • Revmatologie s.r.o. ( Site 0009)

    Brno, 638 00
    Czechia

    Site Not Available

  • CCBR Ostrava s.r.o. ( Site 0001)

    Ostrava, 702 00
    Czechia

    Site Not Available

  • Artroscan s.r.o. ( Site 0007)

    Ostrava - Trebovice, Prague 6
    Czechia

    Site Not Available

  • Artroscan s.r.o. ( Site 0007)

    Ostrava-Trebovice, 722 00
    Czechia

    Site Not Available

  • CCR Czech a.s. ( Site 0003)

    Pardubice, 530 02
    Czechia

    Site Not Available

  • CCR Prague s.r.o ( Site 0004)

    Praha, 130 00
    Czechia

    Site Not Available

  • Fakultni nemocnice v Motole ( Site 0127)

    Praha, 150 06
    Czechia

    Site Not Available

  • Medical Plus s.r.o ( Site 0010)

    Uherske Hradiste, 686 01
    Czechia

    Site Not Available

  • PV - Medical s.r.o. ( Site 0006)

    Zlin, 760 01
    Czechia

    Site Not Available

  • North Estonia Medical Centre Foundation ( Site 0208)

    Tallinn,
    Estonia

    Site Not Available

  • Meditrials Clinical Research Center ( Site 0206)

    Tartu,
    Estonia

    Site Not Available

  • Universitaetsklinik der Charite Berlin ( Site 0023)

    Berlin, 12203
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet ( Site 0021)

    Herne, 44649
    Germany

    Site Not Available

  • U. klinikum Koeln AOER ( Site 0025)

    Koeln, 50937
    Germany

    Site Not Available

  • Herbert Kellner Innere Medizin Rheumatologie und Gastroenterologie ( Site 0022)

    Muenchen, 80639
    Germany

    Site Not Available

  • Klinikum der Universitaet Muenchen - LMU ( Site 0026)

    Muenchen, 80336
    Germany

    Site Not Available

  • St Vincent's University Hospital ( Site 0101)

    Dublin,
    Ireland

    Site Not Available

  • Artrita Klinika ( Site 0215)

    Riga,
    Latvia

    Site Not Available

  • VAKK Dr. Kildos klinika ( Site 0217)

    Kaunas,
    Lithuania

    Site Not Available

  • Klaipedos universitetine ligonine ( Site 0219)

    Klaipeda,
    Lithuania

    Site Not Available

  • Vilniaus universiteto ligonines Santariskiu klinikos ( Site 0218)

    Vilnius,
    Lithuania

    Site Not Available

  • Antonius Ziekenhuis Sneek ( Site 0043)

    Sneek, Friesland 8601 ZK
    Netherlands

    Site Not Available

  • Vrij Universiteit Medisch Centrum ( Site 0044)

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum ( Site 0041)

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Maasstad Ziekenhuis ( Site 0042)

    Rotterdam, 3079 DZ
    Netherlands

    Site Not Available

  • Centrum Medyczne Pratia Katowice ( Site 0059)

    Katowice, Slaskie 40-081
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska, Dr. med. Pawel Hrycaj ( Site 0060)

    Poznan, Wielkopolskie 61-397
    Poland

    Site Not Available

  • NZOZ Osteo-Medic s.c. A. Racewicz, R. Supronik ( Site 0058)

    Bialystok, 15-351
    Poland

    Site Not Available

  • Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 0153)

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Centrum Kliniczno-Badawcze ( Site 0152)

    Elblag, 82-300
    Poland

    Site Not Available

  • Krakow Medical Centre ( Site 0052)

    Krakow, 31-501
    Poland

    Site Not Available

  • NZOZ Reumed ( Site 0051)

    Lublin, 20-582
    Poland

    Site Not Available

  • Pomorskie Cent. Reumatologiczne IM.Dr. Titz-Kosko W Sopocie Sp. Z.o.o. ( Site 0057)

    Sopot, 81-759
    Poland

    Site Not Available

  • Lubelskie Centrum Diagnostyczne ( Site 0053)

    Swidnik, 21-040
    Poland

    Site Not Available

  • NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych ( Site 0151)

    Torun, 87-100
    Poland

    Site Not Available

  • Reumatika ( Site 0055)

    Warszawa, 02-691
    Poland

    Site Not Available

  • Spitalul Judetean de Urgenta Baia Mare Dr Constantin Opris ( Site 0181)

    Baia Mare,
    Romania

    Site Not Available

  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed ( Site 0177)

    Brasov, 500283
    Romania

    Site Not Available

  • Colentina Clinical Hospital ( Site 0231)

    Bucarest, 020125
    Romania

    Site Not Available

  • Clinical Hospital Ioan Cantacuzino ( Site 0184)

    Bucaresti, 020475
    Romania

    Site Not Available

  • Spitalul Clinic Sfanta Maria ( Site 0182)

    Bucharest, 011172
    Romania

    Site Not Available

  • SC Duo Medical SRL ( Site 0183)

    Bucuresti, 010584
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca ( Site 0176)

    Cluj Napoca, 400006
    Romania

    Site Not Available

  • RKMed Center ( Site 0180)

    Iasi, 700127
    Romania

    Site Not Available

  • S.C.Pelican Impex S.R.L ( Site 0232)

    Oradea, 410450
    Romania

    Site Not Available

  • Covamed Serv SRL ( Site 0178)

    Sfantu Gheorghe, 520052
    Romania

    Site Not Available

  • Cabinet Medical Medicina Interna Dr. Triff Carina ( Site 0179)

    Timisoara, 300766
    Romania

    Site Not Available

  • GUZ Regional Clinical Hospital ( Site 0076)

    Saratov, Oktyabrskiy Region 410053
    Russian Federation

    Site Not Available

  • Rheumatology Research Institute n.a. V.A.Nasonova of RAMS ( Site 0061)

    Moscow, 115522
    Russian Federation

    Site Not Available

  • SBHI Leningrad Regional Clinical Hospital ( Site 0065)

    Saint Petersburg, 194291
    Russian Federation

    Site Not Available

  • SPb SBHI Clinical Rheumatological Hospital 25 ( Site 0077)

    Saint Petersburg, 190068
    Russian Federation

    Site Not Available

  • LLC Sanavita ( Site 0074)

    Saint-Petersburg, 195257
    Russian Federation

    Site Not Available

  • Tolyatti City Clinical Hospital 5 ( Site 0069)

    Tolyatti, 445039
    Russian Federation

    Site Not Available

  • Yaroslavl Clinical Hospital for Emergency Care na. NV. Solovyev. ( Site 0075)

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Hospital de Basurto ( Site 0082)

    Bilbao, 48013
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia ( Site 0081)

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 0083)

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Arrixaca ( Site 0085)

    Murcia, 30120
    Spain

    Site Not Available

  • Akdeniz Universitesi Tip Fakultesi Romatoloji Departmani ( Site 0094)

    Antalya, Ankara 07070
    Turkey

    Site Not Available

  • Ankara Numune Egitim Arastirma Hastanesi ( Site 0092)

    Ankara, 06100
    Turkey

    Site Not Available

  • Ankara Universitesi Tıp Fakultesi ( Site 0093)

    Ankara, 06230
    Turkey

    Site Not Available

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0091)

    Ankara, 06100
    Turkey

    Site Not Available

  • Pamukkale Unv. Tip Fak. ( Site 0097)

    Denizli, 20070
    Turkey

    Site Not Available

  • Eskisehir Osmangazi Universitesi Saglık Uygulama Hastanesi ( Site 0099)

    Eskisehir,
    Turkey

    Site Not Available

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0098)

    Istanbul, 34899
    Turkey

    Site Not Available

  • Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari ( Site 0096)

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Cherkassy Regional hospital of Cherkassy Regional council ( Site 0221)

    Cherkassy, 18009
    Ukraine

    Site Not Available

  • MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222)

    Dnipro,
    Ukraine

    Site Not Available

  • MI Dnipropetrovsk Regional Clinical Hosp n a I.I. Mechnikov ( Site 0222)

    Dnipropetrovs k,
    Ukraine

    Site Not Available

  • MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222)

    Dnipropetrovsk, 49005
    Ukraine

    Site Not Available

  • Regional Clinical Hospital. ( Site 0270)

    Ivano-Frankivsk,
    Ukraine

    Site Not Available

  • ME of Health Care Kharkiv City Clinical Hospital #8 ( Site 0262)

    Kharkiv, 61176
    Ukraine

    Site Not Available

  • SI National Institute of therapy n.a L.T. Maloi NAMS of Ukraine ( Site 0261)

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • Khmelnytskyy regional hospital ( Site 0228)

    Khmelnytskyy,
    Ukraine

    Site Not Available

  • Clinic of Modern Rheumatology ( Site 0265)

    Kyiv, 04070
    Ukraine

    Site Not Available

  • Kyivska miska klinichna likarnia N3 ( Site 0266)

    Kyiv, 02125
    Ukraine

    Site Not Available

  • M. D. Strazhesko Institute of Cardiology. ( Site 0264)

    Kyiv, 03680
    Ukraine

    Site Not Available

  • Medical Center Ibn Sina ( Site 0268)

    Kyiv, 04050
    Ukraine

    Site Not Available

  • Communal City Clinical Hospital #4 ( Site 0230)

    Lviv, 79011
    Ukraine

    Site Not Available

  • MI Odesa Regional Clinical Hospital ( Site 0226)

    Odesa, 65117
    Ukraine

    Site Not Available

  • M.V.Sklifosovskyi Poltava Regional Clinical Hospital ( Site 0224)

    Poltava, 36011
    Ukraine

    Site Not Available

  • Vinnitsa Regional Clinical Hospital n.a. Pirogov ( Site 0225)

    Vinnutsya, 21018
    Ukraine

    Site Not Available

  • SRI of Invalid Rehabilitation of Vinnytsia M.I.Pyrogov ( Site 0263)

    Vinnytsia, 21000
    Ukraine

    Site Not Available

  • Zaporizhzha Regional Clinical Hospital ( Site 0223)

    Zaporizhzhya, 69600
    Ukraine

    Site Not Available

  • Whipps Cross University Hospital ( Site 0104)

    London,
    United Kingdom

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.