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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Rheumatoid arthritis (RA) is a systemic chronic auto-inflammatory disorder which imposes a remarkable burden of morbidity and mortality on global health. The complex interaction between genetics, environment, and immunological response contribute to RA pathogenesis. Current treatment comprises conventional disease-modifying anti-rheumatic drugs (DMARDs) followed by biological DMARDs, if necessary, to achieve low disease activity or remission. Therapeutics used in RA had limitations in tolerability, access, and response duration and magnitude. Consequently, implementation of safe adjunctive treatment for RA is urgently needed to boost the therapeutic response.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 23
Maximum Age: 57
Healthy Volunteers: f
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• Aged 23-57 years fulfilling 2010 American College of Rheumatology - European League against Rheumatism (ACR-EULAR) classification criteria for RA (12) and had active inflammatory RA with no limit in disease duration.

• Patients received MTX, nonsteroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids will be allowed to enroll the trial

• Intravenous, intra-articular or intramuscular corticosteroids; intra-articular hyaluronate sodium; biological DMARDs; and other DMARDs will not be permitted less than 4 weeks before the first dose of paroxetine.

Locations
Other Locations
Egypt
Mostafa Bahaa
RECRUITING
Damietta
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2026-02-20
Participants
Target number of participants: 100
Treatments
Active_comparator: control group
group one (control group): 50 patients will receive the conventional DMARDs therapy (methotrexate 7.5 mg IM once weekly) plus placebo tablets
Active_comparator: Comparative group
50 patients will receive the conventional DMARDs therapy (methotrexate 7.5 mg IM once weekly) plus 20 mg paroxetine daily
Sponsors
Leads: Mostafa Bahaa

This content was sourced from clinicaltrials.gov

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