Clinical trial · Interventional
Reconstitution of CD4+CD25highCD127low/-Tcell
Analysis of T Cell Population to Obtain a Free-drug Remission in Patients Affected by Rheumatoid Athritis in Remission Phase Induced by TNF-blocker Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rheumatoid arthritis (RA) is a systemic disabling inflammatory disease, of autoimmune origin characterized by chronic synovial inflammation resulting in joint damage. Treg cell function in patients with active RA is assumed to be impaired, a trend that seems to be reversed by TNFalpha antagonist therapy. Remission is the current treatment goal in RA. An increasing number of patients in clinical trials achieve this goal raising the question whether patients who have been in remission for a prolonged period (sustained remission) still need medication indefinitely. From a decade TNF-blocker therapy have represented a new treatment option for RA patients non responders to conventional DMARDs and some evidence are now available showing that sustainable remission can be maintained achieved after withdrawal of TNF blocker. Objectives: to verify whether in RA patients in prolonged clinical and instrumental remission the percentages of CD4+CD25highCD127low/- T cells could represent a reliable marker of immunological remission and, even more relevant, if the pharmacological reconstitution of this "immune-modulator" Tcell population could contribute to better identify patients with a low risk of relapse after cessation of TNF-blocker therapy. Methods: in RA patients, who fulfilled the 1987 ACR revised criteria, with disease duration ! 5 years, clinical \[Disease Activity Score on 28 joints-DAS28 0.56 ×√(TJC28) + 0.28×√(SJC28) + 0.70×ln(ESR) + 0.014×GH.TJC= Tender Joints Count (from 0 to 28); SJC= Swollen Joints Count (from 0 to 28) ESR=Erythrocyte Sedimentation Rate GH= patient's assessment of general health (VAS range from 0 to 100 mm); disease's flare was considered if: DAS44 \>=2.4/DAS28 \>=3.2.)\], instrumental (joint ultrasonography: sites to be explored wrists are II-III metacarpophalangeal joint bilaterally using Power Doppler signal (grading 0-3); any other joint will be studied if symptomatic) and immunological (circulating CD4+CD25highCD127low/-Tcells and inflammatory cytokines levels) examination will be performed in order to asses, at different levels, disease activity status. Expected results: to identify in RA patients treated with anti-TNF an "exit-strategy" from these drugs based on clinical, imaging and immunologic features indicative of a sustained remission and to verify whether such conditions are able to predict a low incidence of relapse.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TNF-blockers suspension in patients with rheumatoid arthritis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TNF-blockers withdrawal
- description
- Patients on treatment with TNF-blockers plus DMARDs in which a withdrawal of anti-TNF therapy was made.
- interventionNames
- Drug: TNF-blockers suspension in patients with rheumatoid arthritis
- type
- NO_INTERVENTION
- label
- DMARDs control group
- description
- Patients treated with DMARDs only (Methotrexate/Leflunomide), never treated with anti-TNF.
Primary outcomes (1)
- measure
- Proportion of subjects who flare-up after cessation of anti-TNF therapy after 24 months
- timeFrame
- 24 months
- description
- disease flare-up defined as DAS 28 \>3.2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with RA fulfilling the 1987 ACR classification criteria (10) treated with anti-TNF and/or conventional DMARDs for at least 12 months, in prolonged remission (DAS28 \<2.6 or DAS44 \<1.6) for at least 6 months (checked in two consecutive visits 3 months apart), without Glucocorticosteroid (for at least 3 months, before), on a stable treatment for at least 3 months. Exclusion Criteria: * assumption of glucocorticosteroids within the three months before; confounding comorbidities such as fibromyalgia; chronic inflammatory disease other than RA; ongoing infections at the time of enrolment; recent trauma.
References
Publications (0)
Data not yet available