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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8259-038 | Other Identifier | Merck | |
| 2015-004020-65 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment | Clinical response is defined as Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score improvement of ≥2.0 or ≥50% improvement within 3 months of the start of retreatment, relative to the mean of the two consecutive BASDAI scores that defined the flare. Sustained clinical response refers to participants who attained clinical response and maintained BASDAI criteria throughout the 3-month retreatment period. Response data was collected throughout Period 2 (12 months) and censored to include only the first 3 months after retreatment for a disease flare. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (zero) to 10 (2 or more hours)]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Withdrawal Regimens) | 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. |
Inclusion Criteria:
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)
Has a HLA-B27+ gene and 2 or more of the following SpA characteristics:
Has elevated CRP at Screening or evidence of active inflammation in the sacroiliac joints 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 score of ≥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 been such contact, will undergo additional evaluations and receive appropriate treatment for latent TB
Agrees to undergo screening for hepatitis B virus (HBV) and demonstrates negative results for hepatitis B surface antigen (HBsAg) and HBV deoxyribonucleic acid (DNA)
Exclusion Criteria:
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
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
Had a history of, or ongoing, chronic or recurrent infectious disease
Is known to be infected with human immunodeficiency virus (HIV) or seropositive for hepatitis C virus (HCV)
Has had a chest x-ray within 2 months prior to Screening that shows an abnormality suggestive 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 and basal cell carcinomas of the skin and carcinoma in situ of cervix that has been surgically cured)
Has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis
Has a history of or concurrent congestive heart failure of any grade
Has a transplanted organ (with the exception of a corneal transplant performed >= 3 months prior to baseline)
Has current signs or symptoms of significant medical illness which could interfere with 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 or alcohol) problem within the previous 2 years
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FN Brno ( Site 0005) | Brno | 625 00 | Czechia | |||
| Revmatologie s.r.o. ( Site 0009) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36919768 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label Run-In Golimumab QM | Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Run-In |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2017 |
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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).
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|
| Placebo | Biological | Injections of matching placebo for golimumab. |
|
| Up to 3 months following start of retreatment |
| Time to First Disease Flare | The Kaplan-Meier analysis of time to first "flare" in Period 2 is represented by the percentage of participants who experienced a disease flare relative to baseline prior to the first dose of double-blind treatment in Period 2. Disease flare is defined as ASDAS at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1. | Month 3, Month 6, Month 9, and Month 12 |
| Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment) | ASAS20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥20% from Baseline and an absolute improvement from Baseline of ≥1.0 in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline for ASAS20 analysis is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | Up to 12 months |
| Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment) | ASAS20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥20% from Baseline and an absolute improvement from Baseline of ≥1.0 in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline for ASAS20 analysis is defined as the last ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | Up to 12 months |
| Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment) | ASAS40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥40% from Baseline and an absolute improvement from Baseline of ≥2.0 in at least 3 of 4 domains, and 2) No deterioration from Baseline in the potential remaining domain. Baseline for ASAS40 analysis is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | Up to 12 months |
| Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment) | ASAS40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥40% from Baseline and an absolute improvement from Baseline of ≥2.0 in at least 3 of 4 domains, and 2) No deterioration from Baseline in the potential remaining domain. Baseline for ASAS40 analysis is defined as the last ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | Up to 12 months |
| Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment) | ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | Up to 12 months |
| Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment) | ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | Up to 12 months |
| Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment) | BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of double-blind treatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (zero) to 10 (2 or more hours)]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity. | Up to 12 months |
| Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment) | BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of open-label retreatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (zero) to 10 (2 or more hours)]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity. | Up to 12 months |
| Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment) | Inactive disease status is defined as an ASDAS score <1.3. 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 |
| Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment) | Inactive disease status is defined as an ASDAS score <1.3. 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 |
| Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2 | This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE. The analysis includes AEs that occurred through 90 days after the last dose of study treatment. | Up to approximately 15 months |
| Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2 | This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE. | Up to approximately 12 months |
| Up to 12 months |
| Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Reduced Treatment Regimen) | 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 |
| Brno |
| 638 00 |
| Czechia |
| CCBR Ostrava s.r.o. ( Site 0001) | Ostrava | 702 00 | Czechia |
| Artroscan s.r.o. ( Site 0007) | Ostrava-Trebovice | 722 00 | Czechia |
| CCR Czech a.s. ( Site 0003) | Pardubice | 530 02 | Czechia |
| CCR Prague s.r.o ( Site 0004) | Prague | 130 00 | Czechia |
| Fakultni nemocnice v Motole ( Site 0127) | Prague | 150 06 | Czechia |
| Medical Plus s.r.o ( Site 0010) | Uherské Hradiště | 686 01 | Czechia |
| PV - Medical s.r.o. ( Site 0006) | Zlín | 760 01 | Czechia |
| Universitaetsklinik der Charite Berlin ( Site 0023) | Berlin | 12203 | Germany |
| U. klinikum Koeln AOER ( Site 0025) | Cologne | 50937 | Germany |
| Rheumazentrum Ruhrgebiet ( Site 0021) | Herne | 44649 | Germany |
| Klinikum der Universitaet Muenchen - LMU ( Site 0026) | München | 80336 | Germany |
| Herbert Kellner Innere Medizin Rheumatologie und Gastroenterologie ( Site 0022) | München | 80639 | Germany |
| Antonius Ziekenhuis Sneek ( Site 0043) | Sneek | Provincie Friesland | 8601 ZK | Netherlands |
| Vrij Universiteit Medisch Centrum ( Site 0044) | Amsterdam | 1081 HV | Netherlands |
| Leids Universitair Medisch Centrum ( Site 0041) | Leiden | 2333 ZA | Netherlands |
| Maasstad Ziekenhuis ( Site 0042) | Rotterdam | 3079 DZ | Netherlands |
| Prywatna Praktyka Lekarska, Dr. med. Pawel Hrycaj ( Site 0060) | Poznan | Greater Poland Voivodeship | 61-397 | Poland |
| Centrum Medyczne Pratia Katowice ( Site 0059) | Katowice | Silesian Voivodeship | 40-081 | Poland |
| NZOZ Osteo-Medic s.c. A. Racewicz, R. Supronik ( Site 0058) | Bialystok | 15-351 | Poland |
| Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 0153) | Bydgoszcz | 85-168 | Poland |
| Centrum Kliniczno-Badawcze ( Site 0152) | Elblag | 82-300 | Poland |
| Krakow Medical Centre ( Site 0052) | Krakow | 31-501 | Poland |
| NZOZ Reumed ( Site 0051) | Lublin | 20-582 | Poland |
| Pomorskie Cent. Reumatologiczne IM.Dr. Titz-Kosko W Sopocie Sp. Z.o.o. ( Site 0057) | Sopot | 81-759 | Poland |
| Lubelskie Centrum Diagnostyczne ( Site 0053) | Świdnik | 21-040 | Poland |
| NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych ( Site 0151) | Torun | 87-100 | Poland |
| Reumatika ( Site 0055) | Warsaw | 02-691 | Poland |
| Centrul Medical de Diagnostic si Tratament Ambulator Neomed ( Site 0177) | Brasov | 500283 | Romania |
| Clinical Hospital Ioan Cantacuzino ( Site 0184) | Bucaresti | 020475 | Romania |
| SC Duo Medical SRL ( Site 0183) | Bucharest | 010584 | Romania |
| Spitalul Clinic Sfanta Maria ( Site 0182) | Bucharest | 011172 | Romania |
| Colentina Clinical Hospital ( Site 0231) | Bucharest | 020125 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj-Napoca ( Site 0176) | Cluj-Napoca | 400006 | Romania |
| RKMed Center ( Site 0180) | Iași | 700127 | Romania |
| S.C.Pelican Impex S.R.L ( Site 0232) | Oradea | 410450 | Romania |
| Covamed Serv SRL ( Site 0178) | Sfantu Gheorghe | 520052 | Romania |
| Cabinet Medical Medicina Interna Dr. Triff Carina ( Site 0179) | Timișoara | 300766 | Romania |
| GUZ Regional Clinical Hospital ( Site 0076) | Saratov | Oktyabrskiy Region | 410053 | Russia |
| Rheumatology Research Institute n.a. V.A.Nasonova of RAMS ( Site 0061) | Moscow | 115522 | Russia |
| SPb SBHI Clinical Rheumatological Hospital 25 ( Site 0077) | Saint Petersburg | 190068 | Russia |
| SBHI Leningrad Regional Clinical Hospital ( Site 0065) | Saint Petersburg | 194291 | Russia |
| LLC Sanavita ( Site 0074) | Saint Petersburg | 195257 | Russia |
| Tolyatti City Clinical Hospital 5 ( Site 0069) | Tolyatti | 445039 | Russia |
| Yaroslavl Clinical Hospital for Emergency Care na. NV. Solovyev. ( Site 0075) | Yaroslavl | 150003 | Russia |
| Hospital de Basurto ( Site 0082) | Bilbao | 48013 | Spain |
| Hospital Universitario Reina Sofia ( Site 0081) | Córdoba | 14004 | Spain |
| Hospital Universitario La Paz ( Site 0083) | Madrid | 28046 | Spain |
| Hospital Clinico Universitario Virgen de la Arrixaca ( Site 0085) | Murcia | 30120 | Spain |
| Akdeniz Universitesi Tip Fakultesi Romatoloji Departmani ( Site 0094) | Antalya | Ankara | 07070 | Turkey (Türkiye) |
| Ankara Numune Egitim Arastirma Hastanesi ( Site 0092) | Ankara | 06100 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0091) | Ankara | 06100 | Turkey (Türkiye) |
| Ankara Universitesi Tıp Fakultesi ( Site 0093) | Ankara | 06230 | Turkey (Türkiye) |
| Pamukkale Unv. Tip Fak. ( Site 0097) | Denizli | 20070 | Turkey (Türkiye) |
| Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0098) | Istanbul | 34899 | Turkey (Türkiye) |
| Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari ( Site 0096) | Kocaeli | 41380 | Turkey (Türkiye) |
| Cherkassy Regional hospital of Cherkassy Regional council ( Site 0221) | Cherkassy | 18009 | Ukraine |
| MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222) | Dnipropetrovsk | 49005 | Ukraine |
| SI National Institute of therapy n.a L.T. Maloi NAMS of Ukraine ( Site 0261) | Kharkiv | 61039 | Ukraine |
| ME of Health Care Kharkiv City Clinical Hospital #8 ( Site 0262) | Kharkiv | 61176 | Ukraine |
| Kyivska miska klinichna likarnia N3 ( Site 0266) | Kyiv | 02125 | Ukraine |
| M. D. Strazhesko Institute of Cardiology. ( Site 0264) | Kyiv | 03680 | Ukraine |
| Medical Center Ibn Sina ( Site 0268) | Kyiv | 04050 | Ukraine |
| Clinic of Modern Rheumatology ( Site 0265) | Kyiv | 04070 | Ukraine |
| Communal City Clinical Hospital #4 ( Site 0230) | Lviv | 79011 | Ukraine |
| MI Odesa Regional Clinical Hospital ( Site 0226) | Odesa | 65117 | Ukraine |
| M.V.Sklifosovskyi Poltava Regional Clinical Hospital ( Site 0224) | Poltava | 36011 | Ukraine |
| Vinnitsa Regional Clinical Hospital n.a. Pirogov ( Site 0225) | Vinnutsya | 21018 | Ukraine |
| SRI of Invalid Rehabilitation of Vinnytsia M.I.Pyrogov ( Site 0263) | Vinnytsia | 21000 | Ukraine |
| Zaporizhzha Regional Clinical Hospital ( Site 0223) | Zaporizhzhya | 69600 | Ukraine |
| Golimumab QM (Full Treatment Regimen) |
Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| FG002 | Golimumab Q2M (Reduced Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| FG003 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| FG004 | Open-Label Retreatment | Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2: Withdrawal vs Continued Tx |
|
|
| Period 2: Open-Label Retreatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open-Label Run-In Golimumab QM | Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator. |
| BG001 | Golimumab QM (Full Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| BG002 | Golimumab Q2M (Reduced Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| BG003 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| BG004 | Open-Label Retreatment | Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2 | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2 | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2 | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2 | Count of Participants | Participants |
| ||||||||||
| C-Reactive Protein (CRP) Category at Enrollment | The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2 | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Up to 12 months |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment | Clinical response is defined as Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score improvement of ≥2.0 or ≥50% improvement within 3 months of the start of retreatment, relative to the mean of the two consecutive BASDAI scores that defined the flare. Sustained clinical response refers to participants who attained clinical response and maintained BASDAI criteria throughout the 3-month retreatment period. Response data was collected throughout Period 2 (12 months) and censored to include only the first 3 months after retreatment for a disease flare. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (zero) to 10 (2 or more hours)]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to the reduced-treatment regimen or placebo in Period 2, received at least one dose of double-blind study intervention, and experienced a disease flare during Period 2. Per protocol, participants randomized to the Full Treatment Regimen were not included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 months following start of retreatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Disease Flare | The Kaplan-Meier analysis of time to first "flare" in Period 2 is represented by the percentage of participants who experienced a disease flare relative to baseline prior to the first dose of double-blind treatment in Period 2. Disease flare is defined as ASDAS at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Month 3, Month 6, Month 9, and Month 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment) | ASAS20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥20% from Baseline and an absolute improvement from Baseline of ≥1.0 in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline for ASAS20 analysis is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment) | ASAS20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥20% from Baseline and an absolute improvement from Baseline of ≥1.0 in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline for ASAS20 analysis is defined as the last ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to the reduced-treatment regimen or placebo in Period 2, received at least one dose of double-blind study intervention, and experienced a disease flare during Period 2. Per protocol, participants randomized to the Full Treatment Regimen were not included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment) | ASAS40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥40% from Baseline and an absolute improvement from Baseline of ≥2.0 in at least 3 of 4 domains, and 2) No deterioration from Baseline in the potential remaining domain. Baseline for ASAS40 analysis is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment) | ASAS40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥40% from Baseline and an absolute improvement from Baseline of ≥2.0 in at least 3 of 4 domains, and 2) No deterioration from Baseline in the potential remaining domain. Baseline for ASAS40 analysis is defined as the last ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to the reduced-treatment regimen or placebo in Period 2, received at least one dose of double-blind study intervention, and experienced a disease flare during Period 2. Per protocol, participants randomized to the Full Treatment Regimen were not included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment) | ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment) | ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to the reduced-treatment regimen or placebo in Period 2, received at least one dose of double-blind study intervention, and experienced a disease flare during Period 2. Per protocol, participants randomized to the Full Treatment Regimen were not included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment) | BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of double-blind treatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (zero) to 10 (2 or more hours)]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment) | BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of open-label retreatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (zero) to 10 (2 or more hours)]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to the reduced-treatment regimen or placebo in Period 2, received at least one dose of double-blind study intervention, and experienced a disease flare during Period 2. Per protocol, participants randomized to the Full Treatment Regimen were not included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment) | Inactive disease status is defined as an ASDAS score <1.3. 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. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment) | Inactive disease status is defined as an ASDAS score <1.3. 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. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to the reduced-treatment regimen or placebo in Period 2, received at least one dose of double-blind study intervention, and experienced a disease flare during Period 2. Per protocol, participants randomized to the Full Treatment Regimen were not included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 months |
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| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2 | This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE. The analysis includes AEs that occurred through 90 days after the last dose of study treatment. | The analysis population consists of all participants who received at least one dose of study intervention in Period 2. | Posted | Number | Percentage of participants | Up to approximately 15 months |
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| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2 | This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE. | The analysis population consists of all participants who received at least one dose of study intervention in Period 2. | Posted | Number | Percentage of participants | Up to approximately 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Withdrawal Regimens) | 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. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Reduced Treatment Regimen) | 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. | The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to receive golimumab in Period 2, and received at least one dose of double-blind study intervention. | Posted | Number | Percentage of participants | Up to 12 months |
|
Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months.
The safety analysis population includes all participants who received at least one dose of study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-Label Run-In Golimumab QM | Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator. | 0 | 323 | 7 | 323 | 79 | 323 |
| EG001 | Golimumab QM (Full Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. | 0 | 63 | 1 | 63 | 13 | 63 |
| EG002 | Golimumab Q2M (Reduced Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. | 0 | 64 | 1 | 64 | 17 | 64 |
| EG003 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. | 0 | 62 | 1 | 62 | 11 | 62 |
| EG004 | Open-Label Retreatment | Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. | 0 | 63 | 0 | 63 | 11 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Mar 4, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
Not provided
Not provided
| Physician Decision |
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| Withdrawal by Subject |
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| Did not attain inactive disease in Period 1 |
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| Disease Flare, transitioned to Open-label retreatment |
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| Period 2: Withdrawal vs Continued Tx |
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| Period 2: Open-Label Retreatment |
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| Period 2: Withdrawal vs Continued Tx |
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| Period 2: Open-Label Retreatment |
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| Period 2: Withdrawal vs Continued Tx |
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|
| Period 2: Open-Label Retreatment |
|
|
|
| Period 2: Withdrawal vs Continued Tx |
|
|
| Period 2: Open-Label Retreatment |
|
|
|
| Period 2: Withdrawal vs Continued Tx |
|
|
| Period 2: Open-Label Retreatment |
|
|
Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor |
| <0.001 |
| Difference in percentage |
| 34.4 |
| 2-Sided |
| 95 |
| 17.0 |
| 49.7 |
| Superiority |
|
|
| OG002 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
|
|
| OG001 | Golimumab Q2M (Reduced Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG002 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
|
|
|
|
|
| OG001 | Golimumab Q2M (Reduced Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG002 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
|
|
|
|
|
Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG002 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG002 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Golimumab Q2M (Reduced Treatment Regimen) |
Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG002 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Golimumab Q2M (Reduced Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG002 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG003 | Open-Label Retreatment | Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. |
|
|
| Golimumab Q2M (Reduced Treatment Regimen) |
Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG002 | Placebo (Treatment Withdrawal Regimen) | Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
| OG003 | Open-Label Retreatment | Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. |
|
|
| OG001 | Golimumab Q2M and Placebo (Withdrawal Regimens) | Participants were treated with double-blinded SC injections of 50 mg golimumab Q2M alternating with matching placebo to golimumab every other month or with placebo for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. |
|
|
|
| OG001 | Golimumab Q2M (Reduced Treatment Regimen) | Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab. |
|
|
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ≤ 6 mg/L |
|