The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients

NCT ID: NCT04757571

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-12-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Paroxetine

Paroxetine 20 mg daily plus standard therapy

Group Type: EXPERIMENTAL

Paroxetine

Intervention Type: DRUG

Paroxetine 20 mg tablet plus standard therapy

Placebo

Placebo tablet daily plus standard therapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet plus standard therapy

Interventions

Paroxetine

Paroxetine 20 mg tablet plus standard therapy

Intervention Type: DRUG

Placebo

Placebo tablet plus standard therapy

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sadat City University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Samy Abdallah

Lecturer of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Pharmacy

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

Other Identifiers

RS10/2021

Identifier Type: -

Identifier Source: org_study_id