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

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ClinicalTrials.gov Identifier: NCT03253796
Recruitment Status : Active, not recruiting
First Posted : August 18, 2017
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of treatment withdrawal vs 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.

Condition or disease Intervention/treatment Phase
Spondyloarthritis Biological: Golimumab QM: Period 1 (OL) Biological: Golimumab QM: Period 2 (DB) Biological: Golimumab Q2M: Period 2 (DB) Other: Placebo QM: Period 2 (DB) Biological: Golimumab QM: Period 2 (OL) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To evaluate the effect of treatment withdrawal vs 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).
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In Subjects With Non-Radiographic Axial Spondyloarthritis
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : March 26, 2021
Estimated Study Completion Date : March 26, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open-label (OL) GLM SC QM ---> PBO SC QM
In Period 1 participants are treated with OL GLM SC QM; followed by Period 2 where participants are treated with placebo (PBO) SC QM
 Biological: Golimumab QM: Period 1 (OL)
OL monthly injections of active golimumab 50 mg or 100 mg (two 50 mg injections) from Month 0 to Month 9 (Period 1, run-in)
Other Name: MK-8259

Other: Placebo QM: Period 2 (DB)
DB monthly injections of placebo for golimumab for 12 months, or until "flare" (Period 2, treatment withdrawal)

Biological: Golimumab QM: Period 2 (OL)
OL golimumab 50 mg or 100 mg (two 50 mg injections) for 12 months (Period 2, full treatment re-started after "flare")
Other Name: MK-8259
Experimental: OL GLM SC QM ---> DB GLM SC QM
In Period 1 participants are treated with OL GLM SC QM; followed by Period 2 where participants are treated with double-blinded (DB) GLM SC QM
 Biological: Golimumab QM: Period 1 (OL)
OL monthly injections of active golimumab 50 mg or 100 mg (two 50 mg injections) from Month 0 to Month 9 (Period 1, run-in)
Other Name: MK-8259

Biological: Golimumab QM: Period 2 (DB)
DB monthly injections of active golimumab 50 mg or 100 mg (two 50 mg injections) for 12 months, or until "flare" (Period 2, full treatment)
Other Name: MK-8259
Experimental: OL GLM SC QM ---> DB GLM SC Q2M
In Period 1 participants are treated with OL GLM SC QM; followed by Period 2 where participants are treated with DB GLM SC Q2M
 Biological: Golimumab QM: Period 1 (OL)
OL monthly injections of active golimumab 50 mg or 100 mg (two 50 mg injections) from Month 0 to Month 9 (Period 1, run-in)
Other Name: MK-8259

Biological: Golimumab Q2M: Period 2 (DB)
DB monthly injections of golimumab 50 mg or 100 mg (two 50 mg injections), alternating with placebo, for 12 months, or until "flare" (Period 2, reduced treatment)
Other Name: MK-8259


Outcome Measures
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Primary Outcome Measures :
  1. Disease Activity Flare [ Time Frame: Up to 12 months ]
    Percentage of participants without a disease activity "flare" during up to 12 months following randomization to DB therapy


Secondary Outcome Measures :
  1. Clinical Response [ Time Frame: Up to 12 months ]
    Percentage of participants with a clinical response to re-treatment with OL golimumab after a "flare" in Period 2

  2. First Flare [ Time Frame: Up to 12 months ]
    Time to first "flare" in Period 2

  3. Assessment in SpondyloArthritis international Society (ASAS)20 Response [ Time Frame: Up to 12 months ]
    Percentage of participants achieving ASAS20 response (20% reduction in ASAS) in Period 2

  4. ASAS40 Response [ Time Frame: Up to 12 months ]
    Percentage of participants achieving ASAS40 response (40% reduction in ASAS) in Period 2

  5. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response [ Time Frame: Up to 12 months ]
    Percentage of participants achieving a BASDAI50 response (250% reduction in BSDAI) in Period 2

  6. ASAS Partial Remission [ Time Frame: Up to 12 months ]
    Percentage of participants achieving ASAS partial remission in Period 2

  7. Inactive Disease Status [ Time Frame: Up to 12 months ]
    Percentage of participants achieving inactive disease status in Period 2


Other Outcome Measures:
  1. Adverse Events [ Time Frame: Up to 12 months, plus AE follow up ]
    Number of participants who experience at lease one adverse event (AE)

  2. Discontinuations [ Time Frame: Up to 12 months ]
    Number of participants who discontinue treatment due to an AE


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 nr-axSpA with disease duration <= 5 years

  • 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 CRP
    • • Human leukocyte antigen B27 (HLA-B27)+ gene
  • Has a HLA-B27+ gene and 2 or more of the SpA characteristics listed above
  • Has elevated CRP at Screening or evidence of active inflammation in the sacroiliac joints on MRI
  • Has an 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

Exclusion Criteria:

  • Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4
  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253796


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03253796    
Other Study ID Numbers: 8259-038
2015-004020-65 ( EudraCT Number )
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
 Arthritis
Joint Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs