Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people. This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
This study consists of a 12-week Placebo-controlled Period and a 116-week Long-term Extension (LTE), which is composed of a 44-week Main Extension and an 72-week Optional Extension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
182
Subcutaneous (SC) administration
SC Injection
Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)
Glendale, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)
Mesa, Arizona, United States
RECRUITINGArthritis & Osteoporosis Medical Center - La Palma ( Site 1024)
La Palma, California, United States
RECRUITINGTekton Research, LLC. ( Site 1008)
Fort Collins, Colorado, United States
Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
The ACR20 response is a composite measure to evaluate disease activity in RA. ACR20 response is defined as a ≥20% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥20% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0=without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR20 response at Week 12 will be presented.
Time frame: Week 12
Proportion of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
The ACR50 response is a composite measure to evaluate disease activity in RA. ACR50 response is defined as a ≥50% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥50% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0= without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR50 response at Week 12 will be presented.
Time frame: Week 12
Proportion of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
The ACR70 response is a composite measure to evaluate disease activity in RA. ACR70 response is defined as a ≥70% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥70% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0= without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR70 response at Week 12 will be presented.
Time frame: Week 12
Proportion of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP)
The DAS28-CRP is a composite measure of RA disease activity. DAS28-CRP is based upon a statistically-derived index combining the following 4 components: i) tender joint count (TJC) (28 joints; 0=absent, 1=present; TJC28), ii) swollen joint count (SJC) (28 joints; 0=absent, 1=present; SJC28), iii) serum high-sensitivity C-reactive protein (hsCRP), serum value decrease indicates less inflammation, and iv) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease. The index is defined as follows: DAS28-CRP = 0.56 × SQRT(TJC28) + 0.28 × SQRT(SJC28) + 0.36 × ln (hsCRP+1) + 0.014 × ptGA+ 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Remission is indicated by a DAS28-CRP score of \<2.6 and low disease activity (LDA) by a DAS28-CRP score of ≤3.2. The proportion of participants who achieve LDA will be presented.
Time frame: Week 12
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12
The HAQ-DI is a 20-item questionnaire that measures physical function in participants with RA. The questionnaire assesses the degree of difficulty a person has in accomplishing tasks in 8 functional area domains (dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area domain are scored from 0 to 3 (0= without any difficulty; 3= unable to do), with a higher score indicating inability to perform activity. The overall disability score (HAQ-DI) is a summation of the highest score from each domain divided by the number of domains completed and ranges from 0 to 3, with the higher value indicating worse disability. The change from baseline to week 12 in the HAQ-DI score will be presented.
Time frame: Baseline and Week 12
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately Week 142
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Time frame: Up to approximately Week 128
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Sweet Hope Research Specialty, Inc ( Site 1015)
Hialeah, Florida, United States
RECRUITINGHMD Research LLC ( Site 1016)
Orlando, Florida, United States
RECRUITINGGreater Chicago Specialty Physicians - Orland Park ( Site 1043)
Orland Park, Illinois, United States
RECRUITINGAA Medical Research Center ( Site 1027)
Grand Blanc, Michigan, United States
RECRUITINGKansas City Physician Partners ( Site 1032)
Kansas City, Missouri, United States
RECRUITINGPhysician Research Collaboration, LLC ( Site 1002)
Lincoln, Nebraska, United States
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