The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA

NCT04928066 | Completed Phase 4

• 1 other identifier: Tofacitinib-RA QiluH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid

Keywords

Tofacitinib; Iguratimod

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who achieve clinical remission at week 30 using European League Against Rheumatism (EULAR) response criteria DAS28

  The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). 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 erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR \> 5.1; Moderate disease activity: 5.1≥ DAS28 \> 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission.

  week 30

Secondary Outcomes (16)

• The percentage of patients who achieve clinical remission using DAS28-ESR at week 18

  week 18

• The percentage of patients who achieve clinical remission using DAS28-ESR at week 6

  week 6

• Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 30

  week 30

• Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 18

  week 18

• Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 6

  week 6

Study Arms (2)

Tofacitinib (TF)+Iguratimod (IGU)

EXPERIMENTAL

Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.

Drug: Iguratimod; Drug: Tofacitinib; Drug: Pred

Tofacitinib (TF)

OTHER

Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.

Drug: Tofacitinib; Drug: Pred

Interventions

Iguratimod DRUG

Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Also known as: IGU, T-614

Tofacitinib (TF)+Iguratimod (IGU)

Tofacitinib DRUG

Tofacitinib,5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Also known as: TF

Tofacitinib (TF); Tofacitinib (TF)+Iguratimod (IGU)

Pred DRUG

Pred, 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.

Also known as: Prednisone

Tofacitinib (TF); Tofacitinib (TF)+Iguratimod (IGU)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

iguratimod; glucose utilization inhibitor; T 614; tofacitinib; prednylidene; Prednisone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xiaoyun Yang, Dr.

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: March 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)