Health TrialsbyHealthPanel

Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis

ConditionsDifficult-to-treat Rheumatoid ArthritisRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital

About this trial

This study is a multicenter, open-label, randomized controlled trial designed to preliminarily evaluate the efficacy and safety of telitacicept in patients with refractory rheumatoid arthritis during a 24-week treatment period followed by a 2-week follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and Female participants of age >18 years will be enrolled;

Meet the 2021 EULAR criteria for the diagnosis of difficult-to-treat rheumatoid arthritis;

The dose of prednisone should be ≤10 mg or equivalent dose of corticosteroids, and the dose must remain unchanged for at least 4 weeks;

Consent to use effective contraception during the study period (women of childbearing age);

Disqualifiers

Those with specific allergy history (asthma, urticaria, eczema, etc.), or allergic constitution, or hypersensitivity to any component of telitacicept;

Subjects who have received intra-articular, intravenous, intramuscular, or intrarectal (excluding suppositories for anal diseases) corticosteroids within 4 weeks prior to baseline;

Subjects who have used Tripterygium wilfordii glycosides, total glucosides of paeony, Huobahuagen tablets, or other immunosuppressive or anti-inflammatory traditional Chinese medicines or decoctions within 4 weeks prior to baseline;

Subjects currently using non-steroidal anti-inflammatory drugs (excluding acetaminophen) whose dose has not been stable for 4 weeks prior to randomization, or who are unable to continue treatment at the original dose during the trial;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telitacicept 160mg

    Biological/Vaccine

    Telitacicept 160 mg will be administered subcutaneously once weekly for 24 consecutive weeks.

  • Standard therapy

    Drug

    Standard therapy includes DMARDs, GCs, and NSAIDs.

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Telitacicept plus standard therapy groupExperimental treatment 2 interventions
Group B: Standard therapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ACR20 response rate

Time frame
Week 24

Secondary outcomes

1

ACR50 and ACR70 response rates

Time frame
Week 24
2

Change from baseline in SDAI

Time frame
Week 24
3

The proportion of subjects achieving SDAI ≤ 3.3

Time frame
Week 24
4

Change from baseline in CDAI

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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