Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. Last observation carried forward (LOCF) was used for missing data.

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Time frame: from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

CDAI is a composite index for assessing disease activity based on the summation of the counts of Tender Joint Count 28 (TJC28) and Swollen Joint Count 28 (SJC28), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had a baseline and post-baseline assessment. LOCF was used for missing data; LOCF imputation was conducted separately for M12-963 and M12-965 (ie, data from M12-963 was not carried forward to visits in M12-965).

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 2 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 36 (Week 24 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 4 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 6 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 8 of Study M12-963

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 16 (Week 4 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 20 (Week 8 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 24 (Week 12 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 28 (Week 16 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to \< 3.2, and CR was defined as a score \< 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

Time frame: Week 32 (Week 20 of Study M12-965)

Population: Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.