SC Injection

Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.

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.

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.

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.

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.

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.