A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Week 12

Population: The Intent-to-Treat (ITT) population (Period 1) was defined as all participants who were randomized to study treatment. Non-responder imputation was applied.

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).

Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).

Time frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).

Time frame: Baseline, Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Higher score indicate more difficulty in performing daily living activities.

Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Higher score indicate more difficulty in performing daily living activities.

Time frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Higher score indicate more difficulty in performing daily living activities.

Time frame: Baseline, Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Time frame: Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Time frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Time frame: Baseline, Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Time frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Time frame: Baseline, Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled Very Well and the 100 mm end labeled Very Poorly.

Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled Very Well and the 100 mm end labeled Very Poorly.

Time frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled Very Well and the 100 mm end labeled Very Poorly.

Time frame: Baseline, Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled None and the 100 mm end labeled Extreme.

Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled None and the 100 mm end labeled Extreme.

Time frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled None and the 100 mm end labeled Extreme.

Time frame: Baseline, Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Time frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Time frame: Baseline, Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).

Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).

Time frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).

Time frame: Baseline, Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =\<1; or the score on the simplified disease activity index (SDAI) was =\<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).

Time frame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =\<1; or the score on the simplified disease activity index (SDAI) was =\<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).

Time frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =\<1; or the score on the simplified disease activity index (SDAI) was =\<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).

Time frame: Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) \<2.6 indicates remission.

Time frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) \<2.6 indicates remission.

Time frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP \[mg/L\] +1) + 0.014 (PGA \[mm\]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) \<2.6 indicates remission.

Time frame: Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline \>1.2 and DAS28 =\<3.2. Moderate response was achieved if DAS28 improvement from baseline \>0.6 to =\<1.2 and DAS28 =\<5.1; or DAS improvement from baseline \>1.2 and DAS28 \>3.2. No response was achieved if DAS improvement from baseline =\<0.6 (no matter present DAS28 score); or DAS improvement from baseline \>0.6 to =\<1.2 and DAS28 \>5.1.

Time frame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline \>1.2 and DAS28 =\<3.2. Moderate response was achieved if DAS28 improvement from baseline \>0.6 to =\<1.2 and DAS28 =\<5.1; or DAS improvement from baseline \>1.2 and DAS28 \>3.2. No response was achieved if DAS improvement from baseline =\<0.6 (no matter present DAS28 score); or DAS improvement from baseline \>0.6 to =\<1.2 and DAS28 \>5.1.

Time frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline \>1.2 and DAS28 =\<3.2. Moderate response was achieved if DAS28 improvement from baseline \>0.6 to =\<1.2 and DAS28 =\<5.1; or DAS improvement from baseline \>1.2 and DAS28 \>3.2. No response was achieved if DAS improvement from baseline =\<0.6 (no matter present DAS28 score); or DAS improvement from baseline \>0.6 to =\<1.2 and DAS28 \>5.1.

Time frame: Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Population: The ITT population (Period 1) was defined as all participants who were randomized to study treatment.

ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)

Population: The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.

ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Time frame: Weeks 52, 56, 66, 76 and 78

Population: The ITT population (Period 3) was defined as all participants enrolled in Period 3.

Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 1 (without regard to baseline abnormality) is presented.

Time frame: Baseline (Day 1) up to Week 26 (pre-dose)

Population: The analysis population included all randomized participants who received at least 1 dose of study treatment and had laboratory test in Period 1, analyzed by actual treatment received.

Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 2 (without regard to baseline abnormality) is presented.

Time frame: Week 26 dosing up to Week 52 (pre-dose)

Population: The analysis population included all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dost of study treatment in Period 2, and had laboratory test in Period 2, analyzed by actual treatment received.

Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 3 (without regard to baseline abnormality) is presented.

Time frame: Week 52 dosing up to follow-up visit (Week 92)

Population: The analysis population included all participants enrolled and treated in Period 3 who had laboratory test in Period 3.

Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer \>=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer \>=0.70.

Time frame: Baseline up to Week 26 (pre-dose)

Population: The analysis population included all randomized participants who received at least 1 dose of study drug, and had at least 1 ADA measurement in Period 1, analyzed by actual treatment received.

Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer \>=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer \>=0.70.

Time frame: Week 26 dosing up to Week 52 (pre-dose)

Population: The analysis population included all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dose of study treatment in Period 2, and had at least 1 ADA measurement in Period 2, analyzed by actual treatment received.

Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer \>=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer \>=0.70.

Time frame: Week 52 dosing up to follow-up visit (Week 92)

Population: The analysis population included all participants enrolled and treated in Period 3 who had at least 1 ADA measurement in Period 3.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 1 were events between first dose of study drug in Period 1 and up to Week 26 pre-dose assessments that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.

Time frame: Baseline (Day 1) up to Week 26 (pre-dose)

Population: Safety population (Period 1) was defined as all randomized participants who received at least 1 dose of study treatment, analyzed by actual treatment received.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 2 were events between first dose of study drug in Period 2 and up to Week 52 pre-dose assessments that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.

Time frame: Week 26 dosing up to Week 52 (pre-dose)

Population: Safety population (Period 2) was defined as all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dost of study treatment in Period 2, analyzed by actual treatment received.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 3 were events between first dose of study drug in Period 3 and up to Week 92 visit that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.

Time frame: Week 52 dosing up to follow-up visit (Week 92)

Population: Safety population (Period 3) was defined as all participants enrolled and treated in Period 3.

Time frame: Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit

Population: The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 1.

Time frame: Pre-dose on Days 183, 211, 253 and 365

Population: The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 2.

Time frame: Pre-dose on Days 365, 393, 463, 547 and 575

Population: The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 3.

A sub-study was conducted to determine whether participants or their non-healthcare professional caregivers could safely and effectively administer PF-06410293 with the sponsor's prefilled pen (PFP) device.

Time frame: Weeks 56, 58, 60, 62, 64, 66

Population: The analysis population included all participants in the sub-study.