American College of Rheumatology Response Criteria (ACR) 20% (ACR20)

ACR20 is defined as a 20% or greater improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints and b) 20% or greater improvement in \>3 of the 5 components of i) Health Assessment Questionnaire Disability Index (HAQ-DI), ii) Physician Global Assessment of Disease Activity (PGA), iii) Patient Global Assessment (PtGA), iv) Patient Assessment of Pain Severity, and v) high sensitivity C-reactive protein (hsCRP).

Week 16

ACR 50% (ACR50)

ACR50 is defined as a 50% or greater improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints and b) 50% or greater improvement in \>3 of the 5 components of i) Health Assessment Questionnaire Disability Index (HAQ-DI), ii) Physician Global Assessment of Disease Activity (PGA), iii) Patient Global Assessment (PtGA), iv) Patient Assessment of Pain Severity, and v) high sensitivity C-reactive protein (hsCRP).

Week 16

ACR70

ACR70 is defined as a 70% or greater improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints and b) 70% or greater improvement in \>3 of the 5 components of i) Health Assessment Questionnaire Disability Index (HAQ-DI), ii) Physician Global Assessment of Disease Activity (PGA), iii) Patient Global Assessment (PtGA), iv) Patient Assessment of Pain Severity, and v) high sensitivity C-reactive protein (hsCRP).

Week 16

Change from Baseline in HAQ-DI Score at Week 16

The HAQ-DI is a 20-item questionnaire that measures physical function. 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.

Baseline and Week 16

Number of Participants with ≥1 Adverse events

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.

Up to ~Week 147