Clinical trial NCT04928066: The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA
Official title: Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: Tofacitinib
Iguratimod
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RA is a common autoimmune disease that causes joint damage.It is necessary to reach the standard as soon as possible and give effective drugs according to the patient's disease activity to avoid disability. Tofacitinib(TF) is a new type of oral tyrosine kinase inhibitor (JAKi) for the treatment of moderate to severe active RA. However, there is alack of Chinese data on the joint scheme, long-term use, maintenance and stop of TF in the real world. We will use the new JAK combination regimen to treat RA patients, and carry out long-term clinical follow-up for 30 weeks.

Detailed description: Objective: To observe the clinical efficacy and safety of TF combined with/ without IGU for 30 weeks in patients with moderate to severe active RA with different clinical characteristics and subgroups by using a prospective cohort , and to find the best combination scheme of TF.

Eligibility criteria: Inclusion Criteria:

Patients who meet the following inclusion criteria will be eligible to participate in the study:

1. Patients who meet RA standards in 1987 and 2010 or ERA standards in 2012;
2. Age \> 18 years old;
3. the extrapulmonary manifestations of RA were stable;
4. Patients with NSAIDs tolerance;
5. DAS28-ESR is highergreater than 2.6.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. Patients with acute and chronic infection;
2. Platelet count \< 80\*10\^9/L, or white blood cell \< 3\*10\^9/L;
3. ALT or AST is 2 times higher than the upper limit of normal value;
4. Renal insufficiency: serum Cr ≥ 176 umol/L;
5. Pregnant or lactating women (breastfeeding);
6. Have a history of malignant tumor (the cure time is less than 5 years);
7. Patients with severe hypertension and cardiac insufficiency;
8. Other diseases or conditions in which immune suppressants cannot be used;
9. People who are allergic to TF.

Primary outcomes:
measure: The percentage of patients who achieve clinical remission at week 30 using European League Against Rheumatism (EULAR) response criteria DAS28
timeFrame: week 30
Secondary outcomes:
measure: The percentage of patients who achieve clinical remission using DAS28-ESR at week 18
timeFrame: week 18
measure: The percentage of patients who achieve clinical remission using DAS28-ESR at week 6
timeFrame: week 6
measure: Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 30
timeFrame: week 30
measure: Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 18
timeFrame: week 18
measure: Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 6
timeFrame: week 6
measure: Percentage of participants achieving ACR/EULAR remission at week 30
timeFrame: week 30
measure: Percentage of participants achieving ACR/EULAR remission at week 18
timeFrame: week 18
measure: Percentage of participants achieving ACR/EULAR remission at week 6
timeFrame: week 6
measure: Change from baseline Simplified Disease Activity Index (SDAI)
timeFrame: up to week 30
measure: Change from baseline Clinical Disease Activity Index (CDAI)
timeFrame: up to week 30
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: up to week 30
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: up to week 30
measure: Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: up to week 30
measure: Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every time
timeFrame: up to week 30
measure: Incidence of participant withdrawal
timeFrame: up to week 30
measure: Number of participants with"adverse events (AEs)"
timeFrame: up to week 30
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiaoyun Yang, Dr.
role: STUDY_DIRECTOR
References: