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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03253796
Recruitment Status : Active, not recruiting
First Posted : August 18, 2017
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 16, 2017
First Posted Date  ICMJE August 18, 2017
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE November 7, 2017
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
  • 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
  • First Flare [ Time Frame: Up to 12 months ]
    Time to first "flare" in Period 2
  • 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
  • ASAS40 Response [ Time Frame: Up to 12 months ]
    Percentage of participants achieving ASAS40 response (40% reduction in ASAS) in Period 2
  • 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
  • ASAS Partial Remission [ Time Frame: Up to 12 months ]
    Percentage of participants achieving ASAS partial remission in Period 2
  • Inactive Disease Status [ Time Frame: Up to 12 months ]
    Percentage of participants achieving inactive disease status in Period 2
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 16, 2017)
  • Adverse Events [ Time Frame: Up to 12 months, plus AE follow up ]
    Number of participants who experience at lease one adverse event (AE)
  • Discontinuations [ Time Frame: Up to 12 months ]
    Number of participants who discontinue treatment due to an AE
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (MK-8259-038)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Spondyloarthritis
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: Golimumab QM: Period 1 (OL)
    • Other: Placebo QM: Period 2 (DB)
    • Biological: Golimumab QM: Period 2 (OL)
  • 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
    Interventions:
    • Biological: Golimumab QM: Period 1 (OL)
    • Biological: Golimumab QM: Period 2 (DB)
  • 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
    Interventions:
    • Biological: Golimumab QM: Period 1 (OL)
    • Biological: Golimumab Q2M: Period 2 (DB)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2021
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Netherlands,   Poland,   Romania,   Russian Federation,   Spain,   Turkey,   Ukraine
Removed Location Countries Bulgaria,   Estonia,   Ireland,   Latvia,   Lithuania,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT03253796
Other Study ID Numbers  ICMJE 8259-038
2015-004020-65 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP