ClinicalTrials.gg
RecruitingNCT07491016Updated Mar 30, 2026

Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis

An observational study in Telitacicept, Treatment Compliance and Rheumatoid Arthritis, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Zhejiang Provincial People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Patient Compliance with a site in China — 6 open to participants now, 6 under way, none of them phase 3. Patient Compliance · China.

Started
2026
the only one that year
Observational
9 of 23
5 open now
Registered
22nd of 23
by date
Lead sponsor
3 of 23
Zhejiang Provincial People's Hospital

Among the 23 studies in Patient Compliance with a site in China, this one is the only one that started in 2026, is one of 9 observational ones, and was the 22nd registered.

Patient Compliance

752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.

Browse Patient Compliance studies →

Open to participants now

6 of the 23 studies in Patient Compliance with a site in China are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Patient Compliance with a site in China, or all of them as a file.
02

Study summary

The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with baricitinib in the treatment of D2TRA patients

03

Conditions studied

  • Telitacicept
  • Treatment Compliance
  • Rheumatoid Arthritis
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with refractory rheumatoid arthritis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Age 18-85 years
  • 2. Diagnosed with rheumatoid arthritis according to the 2021 EULAR (European Alliance of Associations for Rheumatology) diagnostic criteria
  • 3. The traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease improving anti-rheumatic drugs is ineffective, and telitacicept combined with tofacitinib is required treated patients
  • 4. Voluntarily provided written

Exclusion criteria

Exclusion Criteria:

  • 1. Exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs)
  • 2. Patients with , hematological disorders, or other diseases (excluding rheumatoid arthritis)
  • 3. History of allergy/ to the study medications (Telitacicept or Tofacitinib)
  • 4. Active tuberculosis or active infectious diseases requiring systemic treatment
  • 5. Pregnancy, lactation, or refusal to use during the study
  • 6. Failure to complete the prescribed Telitacicept + Tofacitinib regimen due
  • to:Non-adherence or Severe adverse reactions
  • 7. Other conditions contraindicating participation per investigator judgment
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Telitacicept; Baricitinib. One group of D2TRA subjects receive Telitacicept combine Baricitinib
06

What researchers measure

Primary outcomes

  1. Efficacy of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis

    The disease activity score of 28 joints with erythrocyte sedimentation rate (DAS28-ESR ≤ 2.6, remission; 2.6 \< DAS28 ESR ≤ 3.2, mild activity; 3.2 \< DAS28-ESR ≤ 5.1, moderate activity, and DAS28-ESR \> 5.1, severe activity)

    Time frame: maximum 1 years

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse EventsArthritis

    Liver and kidney function

    Time frame: maximum 1 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Zeng L, Yang K, Wu Y, Yu G, Yan Y, Hao M, Song T, Li Y, Chen J, Sun L. Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases. J Autoimmun. 2024 Sep;148:103291. doi: 10.1016/j.jaut.2024.103291. Epub 2024 Aug 14. PubMed 39146891 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Mar 2027, 12 months later.

Of 55 non-industry observational studies under Patient Compliance, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 12 months is below that.

Counting every sponsor, half of 65 studies reached it within 23 months; a quarter within 10 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2026
First posted
Mar 24, 2026
StartEst.
Mar 1, 2026
Primary completionEst.
Mar 30, 2027
CompletionEst.
Mar 30, 2028
Last update
Mar 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07491016
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Zhenhua Ying (Chief Physician, Zhejiang Provincial People's Hospital) — Principal investigator
First posted
Mar 24, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Mar 30, 2026

Study contacts

Zhenhua Ying
Contact
yingzh2021@163.com
+86-571-3989897128

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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