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Rebamipide in Patients With Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Rebamipide
Placebo
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with active rheumatoid arthritis (disease activity score-28 joints: DAS-28 > 3.2) based on the 2010 American College of Rheumatology (ACR) criteria16 were recruited.

rheumatoid Patients who received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.

Exclusion Criteria:

  1. History of biological DMARDS.
  2. History of gastrointestinal surgery, GI ulceration,GI bleeding
  3. Intolerance or allergy to rebamibide or methotrexate
  4. Smoking or alcohol abuse
  5. Any changes in using medication (changing the dosage or type of medicines)
  6. Receive hormone replacement therapy, warfarin, and other anticoagulants

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    placebo

    rebamipide

    Arm Description

    patients will receive the standard therapy (methotrexate) plus placebo tablets

    100 mg rebamipide taken orally daily plus Methotrexate 7.5 mg weekly

    Outcomes

    Primary Outcome Measures

    ACR20
    based on tender and swollen joint counts, patient's assessment of pain
    Disease activity scale in 28 joints (DAS-28)
    Scale assessing severity of rheumatoid arthritis based on number of tender, swollen joints, erythrocyte sedimentation rate (ESR) levels, and patient self-assessment of his condition (global health assessment). Whereas "28" describes the number of different joints including in the measurement: proximal interphalangeal joints (10 joints), metacarpophalangeal joints (10), wrists (2), elbows (2), shoulders (2), knees (2).
    ACR50 & ACR70 response rate
    based on tender and swollen joint counts, patient's assessment of pain, patient and physician global assessment of arthritis, Health Assessment Questionnaire Disability Index (HAQ DI), and CRP level

    Secondary Outcome Measures

    HAQ-DI (Health Assessment Score- Disability index)
    HAQ-DI (Health Assessment Score- Disability index), in which patients are asked to rate their capacity to perform 20 activities of daily living (ADL). Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section
    TNF-α
    Serum level Tumor necrosis factor- alpha (TNF-α)
    IL-17
    Serum levels of Interleukins (IL)
    CRP
    Serum level of C-reactive protein (CRP)

    Full Information

    First Posted
    December 8, 2021
    Last Updated
    February 21, 2022
    Sponsor
    October 6 University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05166304
    Brief Title
    Rebamipide in Patients With Active Rheumatoid Arthritis
    Official Title
    Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    October 6 University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Although the aetiology of RA remains to be fully elucidated, interleukin (IL)-17 are believed to play a critical role in the pathogenesis of RA. Rebamipide is an antiulcer drug that protects gastric epithelial cells,improves gastric defense mechanisms by increasing gastric mucus. Rebamipide inhibited interleukin (IL)-17, also it inhibits IL-1β-induced RASF proliferation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    patients will receive the standard therapy (methotrexate) plus placebo tablets
    Arm Title
    rebamipide
    Arm Type
    Experimental
    Arm Description
    100 mg rebamipide taken orally daily plus Methotrexate 7.5 mg weekly
    Intervention Type
    Drug
    Intervention Name(s)
    Rebamipide
    Intervention Description
    patients will receive the standard therapy plus 100 mg Rebamipide three times daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    patients will receive the standard therapy (methotrexate) plus placebo tablets
    Primary Outcome Measure Information:
    Title
    ACR20
    Description
    based on tender and swollen joint counts, patient's assessment of pain
    Time Frame
    at baseline and at week 12
    Title
    Disease activity scale in 28 joints (DAS-28)
    Description
    Scale assessing severity of rheumatoid arthritis based on number of tender, swollen joints, erythrocyte sedimentation rate (ESR) levels, and patient self-assessment of his condition (global health assessment). Whereas "28" describes the number of different joints including in the measurement: proximal interphalangeal joints (10 joints), metacarpophalangeal joints (10), wrists (2), elbows (2), shoulders (2), knees (2).
    Time Frame
    at baseline and at week 12
    Title
    ACR50 & ACR70 response rate
    Description
    based on tender and swollen joint counts, patient's assessment of pain, patient and physician global assessment of arthritis, Health Assessment Questionnaire Disability Index (HAQ DI), and CRP level
    Time Frame
    at baseline and at week 12
    Secondary Outcome Measure Information:
    Title
    HAQ-DI (Health Assessment Score- Disability index)
    Description
    HAQ-DI (Health Assessment Score- Disability index), in which patients are asked to rate their capacity to perform 20 activities of daily living (ADL). Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section
    Time Frame
    at baseline and at week 12
    Title
    TNF-α
    Description
    Serum level Tumor necrosis factor- alpha (TNF-α)
    Time Frame
    at baseline and at week 12
    Title
    IL-17
    Description
    Serum levels of Interleukins (IL)
    Time Frame
    at baseline and at week 12
    Title
    CRP
    Description
    Serum level of C-reactive protein (CRP)
    Time Frame
    at baseline and at week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with active rheumatoid arthritis (disease activity score-28 joints: DAS-28 > 3.2) based on the 2010 American College of Rheumatology (ACR) criteria16 were recruited. rheumatoid Patients who received the standard therapy (i.e. one or more conventional DMARDs) for at least three months. Exclusion Criteria: History of biological DMARDS. History of gastrointestinal surgery, GI ulceration,GI bleeding Intolerance or allergy to rebamibide or methotrexate Smoking or alcohol abuse Any changes in using medication (changing the dosage or type of medicines) Receive hormone replacement therapy, warfarin, and other anticoagulants
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Engy Wahsh
    Phone
    01003095692
    Email
    engywahsh@o6u.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Rebamipide in Patients With Active Rheumatoid Arthritis

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