Telitacicept for the Treatment of Refractory RA
ConditionRheumatoid Arthritis (RA)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChinese SLE Treatment And Research Group
About this trial
This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fulfill the classification criteria of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
Refractory RA definition: Insufficient response to a combination of at least two adequate doses of csDMARDs followed by bDMARDs (including but not limited to tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors, T-cell costimulation molecule inhibitors, B-cell targeted drugs) or tsDMARDs (including but not limited to JAK inhibitors) for 12 weeks, with stable drug dosage for at least 6 weeks
For patients treated with glucocorticoid therapy, they must have been on a stable dose of prednisone or prednisone equivalent ≤ 10 mg/day for at least 4 weeks before enrollment
For patients treated with non-steroidal anti-inflammatory drugs, they must have been on a stable dose for at least 2 weeks before screening and enrollment
Disqualifiers
Subjects with other autoimmune diseases
Subjects with severe and poorly controlled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematological, or neurological diseases, or laboratory abnormalities that, in the opinion of the investigator, pose unacceptable risks for participation in the study
Subjects with a history of malignancy (or less than 5 years since clinical remission)
Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period
Trial design
Design model
Single group
Treatments tested in this trial
Telitacicept
DrugTelitacicept 160mg qw subcutaneous injection
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Telitacicept treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ACR20 at week 12
ACR20 is a comprehensive index defined as an improvement of at least 20% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 20%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Time frame
Week 12Secondary outcomes
1
ACR20 at week 24
ACR20 is a comprehensive index defined as an improvement of at least 20% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 20%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Time frame
Week 242
The proportion of patients achieving DAS28 remission or low disease activity at week 12 and week 24
DAS28 evaluates RA severity by quantifying joint inflammation and systemic markers of disease activity.
Time frame
Week 12 and 243
The proportion of patients achieving SDAI remission or low disease activity at week 12 and week 24
Simplified Disease Activity Index (SDAI) is calculated by summing five parameters: Tender Joint Count (TJC28): Number of tender joints out of 28 assessed joints. Swollen Joint Count (SJC28): Number of swollen joints out of 28 assessed joints. Patient Global Assessment (PGA): Patient's self-rated health status on a 0-10 scale (0 = best, 10 = worst). Physician Global Assessment (MDGA): Physician's evaluation of disease activity on a 0-10 scale (0 = best, 10 = worst). C-reactive Protein (CRP): Laboratory value measured in mg/L.
Time frame
Week 12 and 244
ACR50 at week 12 and 24
ACR50 is a comprehensive index defined as an improvement of at least 50% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 50%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Time frame
Week 12 and 24Sponsors and contacts
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Source ClinicalTrials.gov
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