Trial · NCT05644210
Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE
NCT05644210, Unknown, Qilu Hospital of Shandong University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE. Trials, record NCT05644210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05644210
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE
- NCT number
- NCT05644210
- Status
- Unknown
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Qilu Hospital of Shandong University
- Conditions
- Antiphospholipid Syndrome
- Interventions
- Telitacicept, Rituximab, Aspirin, Warfarin, Hydroxychloroquine, Prednisone
- First posted
- 2022-12-09
- Last updated
- 2022-12-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of patients who achieved response(complete response and partial response) in aPL profiles | Week 12 | For the lupus anticoagulant (LAC) test, we defined complete response (CR) as a negative test result and no response(NR) as a positive test result； For the anticardiolipin antibody (aCL)/anti-β2 glycoprotein I (anti-β2GPI)enzyme-linked immunosorbent assay,CR was defined as a titer of\<the 95th percentile, partial response (PR) was defined as a titer of 95th -99th , and NR was defined as a titer of \>the 99th percentile. |
| Secondary | The proportion of patients who achieved response(complete response and partial response) in aPL profiles | Week 24,48 | For the lupus anticoagulant (LAC) test, we defined complete response (CR) as a negative test result and no response(NR) as a positive test result； For the anticardiolipin antibody (aCL)/anti-β2 glycoprotein I (anti-β2GPI)enzyme-linked immunosorbent assay,CR was defined as a titer of\<the 95th percentile, partial response (PR) was defined as a titer of 95th -99th , and NR was defined as a titer of \>the 99th percentile. |
| Secondary | The change of aPL titer | week 12 , 24,48 | titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody |
| Secondary | The changes of the positive number of 7 aPL indicators | week 12, 24,48 | Change in the number of antibody positives. |
| Secondary | The change of clinical efficacy in subgroups with different symptoms | Before the screening,baseline and week 12,24,48 | Thrombocytopenia, haemolytic anemia, nephropathy, heart valve lesions, skin changes (livedo reticularis, leg ulcers) |
| Secondary | The change of aGAPSS score | Before the screening,baseline and week 12,24,48 | The aGAPSS was calculated by adding the points corresponding to the risk factors: three for hyperlipidemia, one for arterial hypertension, five for positive anticardiolipin antibodies, four for positive anti-β2 glycoprotein-I antibodies and four for positive lupus anticoagulant test. |
| Secondary | The change of Damage Index for Antiphospholipid Syndrome (DIAPS) | Before the screening and week 12,24,48 | The score is obtained by adding the output rating for each domain. The instrument demonstrated content, criterion, and construct validity being a precise tool to quantify organ damage in APS. |
| Secondary | The change of Physician Global Assessment (PGA) score . | Before the screening,baseline and week 12,24,48 | PGA is a physician-reported visual analogue scale that provides an overall meas- ure of the subject's current disease activity,the PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity; |
| Secondary | The change of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k) Score | Before the screening,baseline and week 12,24,48 | The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE patients in the previous 10 days. |
| Secondary | The percentage of patients with Lupus Low Disease Activity State (LLDAS) | Before the screening,baseline and week 12,24,48 | LLDAS is defined as: (1) SLE Disease Activity Index (SLEDAI)-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no haemolytic anaemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (scale 0-3) ≤1; (4) a current prednisolone (or equivalent) dose ≤7.5 mg daily; and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05644210
GET https://conductscience.org/api/trials/v1/NCT05644210/registered