Back to resultsThe GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Paroxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
• Patients with active rheumatoid arthritis based on DAS28 score. Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.
Exclusion Criteria:
- Known hypersensitivity to metformin.
- Patients who have a prior diagnosis with diabetes mellitus.
- Patients receive metformin for any other indications.
- Patients with congestive heart failure.
- Patients with a history of myocardial infarction.
- Patients with severe anemia.
- Patients with active infections or other inflammatory diseases.
- Patients receiving biological therapy.
- Pregnancy or lactation.
- Patients with impaired liver functions.
- Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
- Patients with malignancies.
Sites / Locations
- Faculty of PharmacyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Paroxetine
Placebo
Arm Description
Paroxetine 20 mg daily plus standard therapy
Placebo tablet daily plus standard therapy
Outcomes
Primary Outcome Measures
ACR 20% improvement criteria (ACR20) 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
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
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).
Secondary Outcome Measures
GRK2 expression
GRK2 expression in serum
TNF-α
Serum level Tumor necrosis factor- alpha (TNF-α)
Inteleukins
Serum levels of Interleukins (IL) IL-17, IL-1β , IL-6 & IL-10
CRP
Serum level of C-reactive protein (CRP)
Drug Adverse effects
Adverse effect incidence: adverse effect will be reported by patients or their caregivers and recorded by investigator.
Full Information
NCT ID
NCT04757571
First Posted
February 12, 2021
Last Updated
January 16, 2023
Sponsor
Sadat City University
1. Study Identification
Unique Protocol Identification Number
NCT04757571
Brief Title
The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients
Official Title
The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients. A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sadat City University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Among three MAPK families, paroxetine was found to be able to decrease the phosphorylation of ERK. It was reported that paroxetine attenuates the symptoms of collage induced arthritis rats due to its inhibitory effect on T cell activation and infiltration to synovial tissue via suppression of ERK pathway. This study aimed to evaluate the therapeutic efficacy of paroxetine in rheumatoid arthritis. Paroxetine prevents the joint inflammation which is at the very early stage. paroxetine could inhibit GRK2 with selectivity over other GRKs. Medications developed for maintaining the immunologic equilibrium. such as GRK2 inhibitors, will be the novel trends in RA treatment that could avoid the adverse side effects that are common with current treatment options.
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
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paroxetine
Arm Type
Experimental
Arm Description
Paroxetine 20 mg daily plus standard therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet daily plus standard therapy
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
Paroxetine 20 mg tablet plus standard therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet plus standard therapy
Primary Outcome Measure Information:
Title
ACR 20% improvement criteria (ACR20) 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
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
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
week 12
Secondary Outcome Measure Information:
Title
GRK2 expression
Description
GRK2 expression in serum
Time Frame
week 12
Title
TNF-α
Description
Serum level Tumor necrosis factor- alpha (TNF-α)
Time Frame
week 12
Title
Inteleukins
Description
Serum levels of Interleukins (IL) IL-17, IL-1β , IL-6 & IL-10
Time Frame
12 weeks
Title
CRP
Description
Serum level of C-reactive protein (CRP)
Time Frame
12 weeks
Title
Drug Adverse effects
Description
Adverse effect incidence: adverse effect will be reported by patients or their caregivers and recorded by investigator.
Time Frame
12 weeks
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 based on DAS28 score. Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.
Exclusion Criteria:
Known hypersensitivity to metformin.
Patients who have a prior diagnosis with diabetes mellitus.
Patients receive metformin for any other indications.
Patients with congestive heart failure.
Patients with a history of myocardial infarction.
Patients with severe anemia.
Patients with active infections or other inflammatory diseases.
Patients receiving biological therapy.
Pregnancy or lactation.
Patients with impaired liver functions.
Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
Patients with malignancies.
Facility Information:
Facility Name
Faculty of Pharmacy
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abdallah, PhD
Phone
01063340887
Email
Mahmoud.samy@fop.usc.edu.eg
Phone
+201063340887
Email
Mahmoud.samy@fop.usc.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients
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