Paroxetine Safety and Efficacy in Rheumatoid Arthritis

Mostafa Bahaa

Status and phase: Enrolling; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Paroxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT06231745

314879

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 23 to 57 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• patients refusing to give informed consent, diabetes, congestive heart failure, previous adverse reaction to paroxetine, oral prednisolone greater than 10 mg/day, receiving biological DMARDs, severe anemia, active infection, pregnancy or lactation, and clinically significant renal or hepatic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

control group

Active Comparator group

Description:

group one (control group): 50 patients will receive the conventional DMARDs therapy (methotrexate 7.5 mg IM once weekly) plus placebo tablets

Treatment:

Drug: Methotrexate

Comparative group

Active Comparator group

Description:

50 patients will receive the conventional DMARDs therapy (methotrexate 7.5 mg IM once weekly) plus 20 mg paroxetine daily

Treatment:

Drug: Paroxetine

Drug: Methotrexate