Trial · NCT05803135
Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis
NCT05803135, Phase 4, Unknown, Nanfang Hospital, Southern Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis. Trials, record NCT05803135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05803135
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis
- NCT number
- NCT05803135
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 138 participants, estimated
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Conditions
- Rheumatoid Arthritis
- Interventions
- Iguratimod combined with Tofacitinib;
- First posted
- 2023-04-07
- Last updated
- 2023-04-07
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28 | week 24 | The proportion of patients with DAS28-CRP\<2.6 at the end of 24 weeks was compared between the two groups. The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity. |
| Secondary | Percentage of American College of Rheumatology [ACR] 20 Criteria Responders at the end of 24 weeks was compared between the two groups. | week 24 | Percentage of American College of Rheumatology \[ACR\] 20 Criteria Responders at the end of 24 weeks was compared between the two groups. |
| Secondary | Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at the end of 24 weeks was compared between the two groups. | week 24 | Percentage of American College of Rheumatology \[ACR\] 50 Criteria Responders at the end of 24 weeks was compared between the two groups. |
| Secondary | Percentage of American College of Rheumatology [ACR] 70 Criteria Responders at the end of 24 weeks was compared between the two groups. | week 24 | Percentage of American College of Rheumatology \[ACR\] 70 Criteria Responders at the end of 24 weeks was compared between the two groups. |
| Secondary | The change of DAS28 score between the two groups at the end of 24 weeks was compared with the baseline value (week 0) | up to week 24 | The change of DAS28 score between the two groups at the end of 24 weeks was compared with the baseline value (week 0) |
| Secondary | The change of Clinical Disease Activity Index (CDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0) | up to week 24 | The CDAI is a composite score derived from these measures，that is the count of tender joint count（TJC, 0-28）, swollen joint count（SJC, 0-28）, Patient global assessment（PGA）and physician global assessment（PHGA）, each of the last two was CDAI score will be calculated with formula CDAI = TJC + SJC + PGA + PHGA. CDAI \> 22 is considered high disease activity; 10 \<CDAI ≤ 22, moderate disease activity; 2.8 \<CDAI ≤10, low disease activity; remission is CDAI score ≤2.8. |
| Secondary | The change of Simplified Disease Activity Index (SDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0) | up to week 24 | The SDAI is a composite score derived from these measures，that is the count of tender joint count（TJC, 0-28）, swollen joint count（SJC, 0-28）, C-reactive protein (CRP, mg/L), Patient global assessment（PGA）and physician global assessment（PHGA）, each of the last two was assessed on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease. SDAI score will be calculated with formula SDAI = TJC + SJC + PGA+PHGA+ CRP. SDAI score exceeding 26 is considered high disease activity; 11 \<SDAI ≤26，moderate disease activity; 3.3 \<SDAI ≤11, low disease activity; remission is SDAI score ≤ 3.3. |
| Secondary | The percentage of patients who achieve clinical remission at week 12 using European League Against Rheumatism (EULAR) response criteria DAS28 | week 12 | The proportion of patients with DAS28-CRP\<2.6 at the end of 12 weeks was compared between the two groups. The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity. |
| Secondary | The proportion of patients with SDAI≤3.3 at the end of 24 weeks was compared between the two groups. | week 24 | The proportion of patients with SDAI≤3.3 at the end of 24 weeks was compared between the two groups. |
| Secondary | The proportion of patients with CDAI≤2.8 at the end of 24 weeks was compared between the two groups. | week 24 | The proportion of patients with CDAI≤2.8 at the end of 24 weeks was compared between the two groups. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/NCT05803135
GET https://conductscience.org/api/trials/v1/NCT05803135/registered