Proportion of participants who remained in LDA DAS28-ESR <3.2 at Week 52 is presented below.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

Proportion of participants who remained in Remission (DAS28-ESR <2.6) at Week 52.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

Proportion of participants who achieved remission (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 2. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

Flare is defined as the criteria of loss of LDA plus ≥0.6 unit worsening in DAS28-ESR score during period 2.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

SDAI and CDAI are defined as:

1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

SDAI and CDAI are defined as:

1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization

SDAI and CDAI are defined as:

1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

SDAI and CDAI are defined as:

1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

Participants were asked to answer the question "In general how would you rate your health over the last 2 3 weeks?" by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

Participants were asked to answer the question "In general how would you rate your health over the last 2-3 weeks?" by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.

The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.

The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).

The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.

The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.