Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis

Sponsor
Ain Shams University
Study ID
NCT07497282
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • venlafaxine extended-release (XR) — DRUG
    35 patients will receive the standard RA treatment in addition to venlafaxine extended-release (XR) initiated at a dose of 75 mg/day for one week to ensure tolerability, followed by an increase to 150 mg/day, which will be maintained for the duration of the study (12 weeks)
  • Standard conventional Rheumatoid Arthritis Therapy — OTHER
    35 patients will receive the standard treatment of RA, which will be maintained for the duration of the study (12 weeks).

Study Details

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by persistent inflammation of the joints, leading to pain, swelling, disability, and reduced quality of life. Current therapies, although effective, may have limited efficacy or tolerability in some patients. Biological DMARDs are often associated with adverse effects, including increased risk of serious infections and heart failure. Long-term use may also increase the risk of malignancies. These limitations, together with their high cost. Venlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI), has shown potential anti-inflammatory properties in addition to its antidepressant effects. This study aims to evaluate the efficacy and safety of venlafaxine as an adjunct therapy in the management of rheumatoid arthritis.

Key Dates

First listed
Mar 27, 2026
Start date
Mar 26, 2026
Status verified
Mar 2026
Primary completion
Oct 26, 2026
Completion
Dec 26, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Venlafaxine Group
    Venlafaxine extended-release (XR) initiated at a dose of 75 mg/day for one week to ensure tolerability, followed by an increase to 150 mg/day, which will be maintained for the duration of the study (12 weeks)
  • Active Comparator: Control Group (Standard Therapy)
    The standard treatment for Rheumatoid Arthritis, which will be maintained for the entire 12-week study period \[Standard treatment of RA includes one or more conventional DMARDs (methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) with or without low dose corticosteroids\].

Primary Outcome Measure

Change in Disease Activity Score 28 (DAS28-CRP) [ Time Frame: Baseline and 3 months ]

Central Contacts

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