Trial · NCT01988506
Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases
NCT01988506, Phase 2, Completed, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases. Trials, record NCT01988506. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01988506
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases
- NCT number
- NCT01988506
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus, Psoriasis, Behcet's Disease, Wegener's Granulomatosis, Takayasu's Disease, Crohn's Disease, Ulcerative Colitis, Autoimmune Hepatitis, Sclerosing Cholangitis, Gougerot-sjögren, Idiopathic Thrombocytopenic Purpura, Systemic Sclerosis
- Interventions
- Interleukin 2
- First posted
- 2013-11-20
- Last updated
- 2021-07-20
- Other registries' IDs
- eudract:2013-001232-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentages of Tregs | Day8 | Change in Treg percentage (percentages of Tregs within the CD4+ lymphocytes) at Day-8 after administration of low-dose of IL2 compared to baseline (Day0) |
| Secondary | Percentages of Tregs | Day 15, 29, 85, 183, 240, 360 and 540 | Changes in Treg percentage at Day 15, 29, 85, 183, 240, 360 and 540 compared to baseline (Day0) |
| Secondary | inflammation markers (CRP and CRP ultra sensible) | Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540 | Changes in levels of inflammation markers |
| Secondary | markers of inflammatory anemia (Hemoglobin, serum iron level, transferrin) ferritin | Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540 | Changes in levels of inflammation markers |
| Secondary | Number of relapses | up to Day540 | |
| Secondary | CGI-sev, CGI-activity and CGI-eff scales | Day 85, 183, 240, 360 and 540 | Change in the clinical global impression severity and efficacy scale (CGI-sev, CGI-act and CGI-eff scales) at Day 85, 183, 240, 360 and 540 compared to baseline (Day1) |
| Secondary | EuroQL-5 scale | Day 183 | Change in the quality of life (EuroQL-5 scale) |
| Secondary | Evolution of clinical, biological or radiological criteria specific to each disease | up to Day 540 | Changes in disease-specific score and/or evolution of clinical, biological or radiological criteria specific to each disease |
| Secondary | Safety Assessment | up to Day 540 | Safety Assessment all along the observation period (Day-1 to Day-240): Safety assessment will include vital signs, adverse events and concomitant medications collection as well as biology during the 6 months of the treatment period; .In addition, the evolution of the disease will be followed up to 1 year after IL2- treatment stop. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30472651 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01988506
GET https://conductscience.org/api/trials/v1/NCT01988506/registered