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Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis
Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis

NCT07497282

Not Yet RecruitingPhase 2

Sponsor: Ain Shams University

Conditions: Rheumatoid Arthritis

Interventions: venlafaxine extended-release (XR), Standard conventional Rheumatoid Arthritis Therapy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Adult patients with definite RA according to ACR/ EULAR 2010 criteria.
* Patients on stable DMARDs+/- steroid regimen for at least 6 months.
* Patients with moderate to high disease activity (DAS28 ≥ 3.2) despite treatment

Exclusion Criteria:

* Patients receiving biologics or targeted DMARDs
* Known hypersensitivity to venlafaxine or any of its components.
* Concurrent Use of MAOIs
* Women who are pregnant or breastfeeding.
* Uncontrolled hypertension
* Unstable Heart Conditions
* Patients receiving any other anti-depressant
* Psychiatrically unstable patients as indicated by a history of psychosis or mania, current suicidal ideation, current substance abuse or dependence.
* Renal dysfunction (creatinine clearance \<60 mL/min)
* Hepatic dysfunction (ALT and AST more than 3 times upper normal limits)
* Patients with active major bleeding or high risk of bleeding