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Rheumatoid ArthritisPhase 2NCT07497282

Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis

A Phase 2 study testing venlafaxine extended-release (XR) and Standard conventional Rheumatoid Arthritis Therapy in people with Rheumatoid Arthritis, run by Ain Shams University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
venlafaxine extended-release (XR) and Standard conventional Rheumatoid Arthritis Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
26 Mar 2026to 26 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sara Ahmed Ibrahim Ahmed, Teaching Assistant at Faculty contact

02 01016069393

Sara.ahmed18@pharma.asu.edu.eg

Hend Magraby Magraby, Associate Professor of Rheumat contact

01114911897

hendms@gmail.com

About this study

Official title: The Effect of Venlafaxine as an Adjunct Therapy on The Clinical Outcome of Rheumatoid Arthritis Patients

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.

Read the detailed description

Eligible patients will be randomly assigned using block randomization to one of the following groups:

Venlafaxine group: 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) The control group: 35 patients will receive the standard treatment of RA, which will be maintained for the duration of the study (12 weeks).

At baseline the following data will be collected from the patient :

Age - Gender- Body mass index (BMI) - Medical history- Medication history- Smoking status- Disease duration- Dose of corticosteroids if present.

Efficacy evaluation Serum CRP and ESR will be assessed at baseline and after 3 months using routine analysis

  • Disease activity using DAS-28-CRP Disease severity will be assessed using DAS-28-CRP at baseline and after 3 months Safety assessment All patients will be assessed on a monthly basis during clinic visits and on a weekly basis during phone calls to assess the adverse effects of venlafaxine. All patients will be educated about the study protocol and will be required to report the occurrence of any of them.

Serum biomarker A blood ample will be withdrawn from each patient at baseline and after 3 month and the separated sera will be stored at -80o C till analysis. These sera will be used to assess the level of VEGF using commercial ELISA kits.

Quality of life assessment using health assessment questionnaire (HAQ-DI)

Being tested
venlafaxine extended-release (XR), Standard conventional Rheumatoid Arthritis Therapy
Keywords
Rheumatoid arthritis, Venlafaxine, Disease activity score (DAS28), Vascular endothelial growth factor (VEGF), Quality of life
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 TherapyOther

    35 patients will receive the standard treatment of RA, which will be maintained for the duration of the study (12 weeks).

Study groups in NCT07497282
Study groupRoleWhat they receive
Venlafaxine GroupExperimentalVenlafaxine 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)
Receives: Drug: venlafaxine extended-release (XR)
Control Group (Standard Therapy)Active comparatorThe 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].
Receives: Other: Standard conventional Rheumatoid Arthritis Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Disease Activity Score 28 (DAS28-CRP)

    Disease severity will be assessed using DAS-28-CRP Disease activity will be assessed using the Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP), a validated composite index that includes tender joint count (28 joints), swollen joint count (28 joints), C-reactive protein (CRP), and patient global assessment of health.

    The DAS28-CRP score ranges approximately from 0 to 9.4, with higher scores indicating higher disease activity and worse outcomes.

    Measured: Baseline and 3 months

Secondary outcomes (5)

  1. Change in C-reactive protein (CRP)

    Serum C-reactive protein (CRP) levels will be measured as an indicator of systemic inflammation.

    CRP is expressed in mg/L, with higher values indicating increased inflammatory activity.

    Measured: Baseline and 3 months

  2. Change in erythrocyte sedimentation rate (ESR)

    Erythrocyte sedimentation rate (ESR) will be measured as a marker of inflammation.

    ESR is expressed in mm/hour, with higher values indicating increased inflammatory activity.

    Measured: Baseline and 3 months

  3. Change in serum vascular endothelial growth factor (VEGF)

    To investigate the change in serum vascular endothelial growth factor (VEGF) levels before and after venlafaxine treatment.

    A blood sample will be withdrawn from each patient at baseline and after 3 month and the separated sera will be stored at -80o C till analysis. These sera will be used to assess the level of VEGF using commercial ELISA kits.

    Measured: at baseline and after 3 months.

  4. safety and tolerability of venlafaxine

    To evaluate the safety and tolerability of venlafaxine through monitoring and documentation of potential adverse events during the study period

    Measured: at baseline and after 3 months.

  5. Health assessment questionnaire HAQ-DI.

    It consists of 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 2-3 questions per domain.

    Each question is scored from 0 (no difficulty) to 3 (unable to do). The domain score is determined by the highest response within that domain. If an assistive device or help from another person is required, the minimum score for that domain is 2 (unless the score is already ≥ 2).

    The total HAQ-DI score is calculated by summing the 8 domain scores and dividing by 8. The final score ranges from 0 to 3, with higher scores indicating greater disability.

    Measured: at baseline and after 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start26 Mar 2026 (estimated)
  3. Primary completion26 Oct 2026 (estimated)
  4. Study completion26 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will receive venlafaxine extended-release in addition to standard rheumatoid arthritis therapy.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07497282
Sponsor's protocol ID
REC # 407
Status last verified
Mar 2026
First submitted
19 Jan 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to institutional policies and to protect participant confidentiality.

Publications

  • Arleevskaya, M., Takha, E., Petrov, S., Kazarian, G., Novikov, A., & Larionova, R. (2021). Causal risk and protective factors in rheumatoid arthritis : A genetic update. Journal of Translational Autoimmunity, 4, 100119. https://doi.org/10.1016/j.jtauto.2021.100119 BASSEL EL-ZORKANY, M.D., W. A. M. D. ., & LOBNA A. MAGED, M.D., N. E.-G. M. D. . M. (2023). Evaluation of Rheumatoid Arthritis Knowledge among a Cohort of 1004 Healthy Egyptians. The Medical Journal of Cairo University, 91(03), 225-0. https://doi.org/10.21608/mjcu.2023.307506 Bullock, J., Rizvi, A. A., Saleh, A. M., & Ahmed, S. (2018). Rheumatoid Arthritis : A Brief Overview of the Treatment. 33328, 501-507. https://doi.org/10.1159/000493390 Chen, C. Y., Yeh, Y. W., Kuo, S. C., Liang, C. S., Ho, P. S., Huang, C. C., Yen, C. H., Shyu, J. F., Lu, R. B., & Huang, S. Y. (2018). Differences in immunomodulatory properties between venlafaxine and paroxetine in patients with major depressive disorder. Psychoneuroendocrinology, 87(325), 108-118. https://doi.org/10.1016/j.psyneuen.2017.10.009 Chen, L., Zeng, X., Zhou, S., Gu, Z., & Pan, J. (2022). Correlation Between Serum Tumor Necrosis Factor-Alpha , Serum Interleukin-6 and White Matter Integrity Before and After the Treatment of Drug-Naïve Patients With Major Depressive Disorder. 16(July), 1-9. https://doi.org/10.3389/fnins.2022.948637 El Meidany, Y. M., El Gaafary, M. M., & Ahmed, I. (2003). Cross-cultural adaptation and validation of an Arabic Health Assessment Questionnaire for use in rheumatoid arthritis patients. Joint Bone Spine, 70(3), 195-202. https://doi.org/10.1016/S1297-319X(03)00004-6 F., W. (1989). The Health Assessment Questionnaire (HAQ) Disability Index (DI) Of The Clinical Health Assessment Questionnaire (Version 96.4). Arthritis Rheum., 32(Di), 2-7. Gharib, M., Elbaz, W., Darweesh, E., & Sabri, N. A. (2021). Ef fi cacy and Safety of Metformin Use in Rheumatoid Arthritis : A Randomized Controlled Study. 12(September), 1-9. https://doi.org/10.3389

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing venlafaxine extended-release (XR) and Standard conventional Rheumatoid Arthritis Therapy in people with Rheumatoid Arthritis, run by Ain Shams University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara Ahmed Ibrahim Ahmed, Teaching Assistant at Faculty (02 01016069393, Sara.ahmed18@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Disease Activity Score 28 (DAS28-CRP) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07497282, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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