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

NCT03253796 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: 8259-038MK-8259-0382015-004020-65
• Study Type: interventional
• Target: 323
• Locations: 9 countries
• Sites: 71

Brief 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.

Conditions

Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Without a Disease Activity Flare During Period 2

  Disease flare is defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1 relative to baseline prior to the first dose of double-blind treatment in Period 2. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually scored on a numeric scale of 0 to 10, with 0 being low activity/impact and 10 being high activity/impact. The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity.

  Up to 12 months

Secondary Outcomes (14)

• Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment

  Up to 3 months following start of retreatment

• Time to First Disease Flare

  Month 3, Month 6, Month 9, and Month 12

• Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment)

  Up to 12 months

• Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment)

  Up to 12 months

• Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment)

  Up to 12 months

Other Outcomes (2)

• Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Withdrawal Regimens)

  Up to 12 months

• Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Reduced Treatment Regimen)

  Up to 12 months

Study Arms (4)

GLM SC QM (Full Treatment Regimen)

EXPERIMENTAL

Period 1: participants are treated with open-label (OL) GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded SC GLM QM for up to 12 months

Biological: Golimumab

GLM SC Q2M (Reduced Treatment Regimen)

EXPERIMENTAL

Period 1: participants are treated with OL GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded GLM SC every other month alternating with matching placebo to GLM every other month for up to 12 months

Biological: Golimumab; Biological: Placebo

Placebo (Treatment Withdrawal Regimen)

PLACEBO COMPARATOR

Period 1: participants are treated with OL GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded placebo for up to 12 months

Biological: Golimumab; Biological: Placebo

OL GLM Retreatment

EXPERIMENTAL

Participants who experience a disease flare during double-blinded treatment in Period 2 will discontinue blinded treatment and receive OL GLM SC QM.

Biological: Golimumab

Interventions

Golimumab BIOLOGICAL

Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.

Also known as: MK-8259, Simponi®

GLM SC Q2M (Reduced Treatment Regimen); GLM SC QM (Full Treatment Regimen); OL GLM Retreatment; Placebo (Treatment Withdrawal Regimen)

Placebo BIOLOGICAL

Injections of matching placebo for golimumab.

GLM SC Q2M (Reduced Treatment Regimen); Placebo (Treatment Withdrawal Regimen)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is not of reproductive potential, or is of reproductive potential and agrees to avoid becoming 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 of sacroiliitis associated with spondyloarthropathy and 1 or more of the following spondyloarthritis (SpA) characteristics:
• Inflammatory back pain
• Arthritis (physician-diagnosed)
• Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)
• 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, acute uveitis, reactive arthritis, or IBD)
• Elevated C-reactive protein (CRP)

You may not qualify if:

• Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional x-rays
• Is a nursing or pregnant female, or intends to become pregnant within 6 months after receiving trial medication
• Intends to donate eggs (female participants) or sperm (male participants) while receiving trial medication or within 6 months after trial medication
• Has any clinically significant condition or situation that would interfere with the trial 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-drug period 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 is longer)
• Bacille Calmette-Guerin (BCG) vaccination (12 months off drug)
• Has any systemic inflammatory condition, including psoriatic arthritis, active Lyme disease, systemic lupus erythematosus, infectious arthritis, vasculitis, parvovirus infection, 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 6 months prior to Screening
• Has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
• Had a serious infection, has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 2 months prior to Baseline

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (71)

FN Brno ( Site 0005)

Brno, 625 00, Czechia

Location

Revmatologie s.r.o. ( Site 0009)

Brno, 638 00, Czechia

Location

CCBR Ostrava s.r.o. ( Site 0001)

Ostrava, 702 00, Czechia

Location

Artroscan s.r.o. ( Site 0007)

Ostrava-Trebovice, 722 00, Czechia

Location

CCR Czech a.s. ( Site 0003)

Pardubice, 530 02, Czechia

Location

CCR Prague s.r.o ( Site 0004)

Prague, 130 00, Czechia

Location

Fakultni nemocnice v Motole ( Site 0127)

Prague, 150 06, Czechia

Location

Medical Plus s.r.o ( Site 0010)

Uherské Hradiště, 686 01, Czechia

Location

PV - Medical s.r.o. ( Site 0006)

Zlín, 760 01, Czechia

Location

Universitaetsklinik der Charite Berlin ( Site 0023)

Berlin, 12203, Germany

Location

U. klinikum Koeln AOER ( Site 0025)

Cologne, 50937, Germany

Location

Rheumazentrum Ruhrgebiet ( Site 0021)

Herne, 44649, Germany

Location

Klinikum der Universitaet Muenchen - LMU ( Site 0026)

München, 80336, Germany

Location

Herbert Kellner Innere Medizin Rheumatologie und Gastroenterologie ( Site 0022)

München, 80639, Germany

Location

Antonius Ziekenhuis Sneek ( Site 0043)

Sneek, Provincie Friesland, 8601 ZK, Netherlands

Location

Vrij Universiteit Medisch Centrum ( Site 0044)

Amsterdam, 1081 HV, Netherlands

Location

Leids Universitair Medisch Centrum ( Site 0041)

Leiden, 2333 ZA, Netherlands

Location

Maasstad Ziekenhuis ( Site 0042)

Rotterdam, 3079 DZ, Netherlands

Location

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

Poznan, Greater Poland Voivodeship, 61-397, Poland

Location

Centrum Medyczne Pratia Katowice ( Site 0059)

Katowice, Silesian Voivodeship, 40-081, Poland

Location

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

Bialystok, 15-351, Poland

Location

Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 0153)

Bydgoszcz, 85-168, Poland

Location

Centrum Kliniczno-Badawcze ( Site 0152)

Elblag, 82-300, Poland

Location

Krakow Medical Centre ( Site 0052)

Krakow, 31-501, Poland

Location

NZOZ Reumed ( Site 0051)

Lublin, 20-582, Poland

Location

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

Sopot, 81-759, Poland

Location

Lubelskie Centrum Diagnostyczne ( Site 0053)

Świdnik, 21-040, Poland

Location

NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych ( Site 0151)

Torun, 87-100, Poland

Location

Reumatika ( Site 0055)

Warsaw, 02-691, Poland

Location

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

Brasov, 500283, Romania

Location

Clinical Hospital Ioan Cantacuzino ( Site 0184)

Bucaresti, 020475, Romania

Location

SC Duo Medical SRL ( Site 0183)

Bucharest, 010584, Romania

Location

Spitalul Clinic Sfanta Maria ( Site 0182)

Bucharest, 011172, Romania

Location

Colentina Clinical Hospital ( Site 0231)

Bucharest, 020125, Romania

Location

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

Cluj-Napoca, 400006, Romania

Location

RKMed Center ( Site 0180)

Iași, 700127, Romania

Location

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

Oradea, 410450, Romania

Location

Covamed Serv SRL ( Site 0178)

Sfântu Gheorghe, 520052, Romania

Location

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

Timișoara, 300766, Romania

Location

GUZ Regional Clinical Hospital ( Site 0076)

Saratov, Oktyabrskiy Region, 410053, Russia

Location

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

Moscow, 115522, Russia

Location

SPb SBHI Clinical Rheumatological Hospital 25 ( Site 0077)

Saint Petersburg, 190068, Russia

Location

SBHI Leningrad Regional Clinical Hospital ( Site 0065)

Saint Petersburg, 194291, Russia

Location

LLC Sanavita ( Site 0074)

Saint Petersburg, 195257, Russia

Location

Tolyatti City Clinical Hospital 5 ( Site 0069)

Tolyatti, 445039, Russia

Location

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

Yaroslavl, 150003, Russia

Location

Hospital de Basurto ( Site 0082)

Bilbao, 48013, Spain

Location

Hospital Universitario Reina Sofia ( Site 0081)

Córdoba, 14004, Spain

Location

Hospital Universitario La Paz ( Site 0083)

Madrid, 28046, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca ( Site 0085)

Murcia, 30120, Spain

Location

Akdeniz Universitesi Tip Fakultesi Romatoloji Departmani ( Site 0094)

Antalya, Ankara, 07070, Turkey (Türkiye)

Location

Ankara Numune Egitim Arastirma Hastanesi ( Site 0092)

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0091)

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Universitesi Tıp Fakultesi ( Site 0093)

Ankara, 06230, Turkey (Türkiye)

Location

Pamukkale Unv. Tip Fak. ( Site 0097)

Denizli, 20070, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0098)

Istanbul, 34899, Turkey (Türkiye)

Location

Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari ( Site 0096)

Kocaeli, 41380, Turkey (Türkiye)

Location

Cherkassy Regional hospital of Cherkassy Regional council ( Site 0221)

Cherkassy, 18009, Ukraine

Location

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

Dnipropetrovsk, 49005, Ukraine

Location

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

Kharkiv, 61039, Ukraine

Location

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

Kharkiv, 61176, Ukraine

Location

Kyivska miska klinichna likarnia N3 ( Site 0266)

Kyiv, 02125, Ukraine

Location

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

Kyiv, 03680, Ukraine

Location

Medical Center Ibn Sina ( Site 0268)

Kyiv, 04050, Ukraine

Location

Clinic of Modern Rheumatology ( Site 0265)

Kyiv, 04070, Ukraine

Location

Communal City Clinical Hospital #4 ( Site 0230)

Lviv, 79011, Ukraine

Location

MI Odesa Regional Clinical Hospital ( Site 0226)

Odesa, 65117, Ukraine

Location

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

Poltava, 36011, Ukraine

Location

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

Vinnutsya, 21018, Ukraine

Location

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

Vinnytsia, 21000, Ukraine

Location

Zaporizhzha Regional Clinical Hospital ( Site 0223)

Zaporizhzhya, 69600, Ukraine

Location

Related Publications (1)

• Weinstein CLJ, Sliwinska-Stanczyk P, Hala T, Stanislav M, Tzontcheva A, Yao R, Berd Y, Curtis SP, Philip G. Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK). Rheumatology (Oxford). 2023 Nov 2;62(11):3601-3609. doi: 10.1093/rheumatology/kead112.

  PMID: 36919768 RESULT

MeSH Terms

Conditions

Spondylarthritis

Interventions

golimumab

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (either every month \[QM\] or every 2 months \[Q2M\]) on the incidence of a "flare" during up to 12 months in Period 2 (blinded therapy).

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: November 7, 2017
• Primary Completion: March 17, 2021
• Study Completion: March 17, 2021
• Last Updated: July 28, 2023
• Results First Posted: May 4, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

PL (11); RO (10); DE (5); ES (4); NL (4); TU (7); CZ (9); RU (7); UA (14)