Study Comparing The Effect On Disease Activity When Reduc... | NCT00858780

ID	Type	Description	Link
B1801016

Label	Type	Description	Intervention Names
1	Active Comparator	50mg once weekly + methotrexate	Drug: Etanercept
2	Active Comparator	25mg once weekly + methotrexate	Drug: Etanercept
3	Placebo Comparator	once weekly + methotrexate	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug	50 mg etanercept once weekly + methotrexate	1
Etanercept

Measure	Description	Time Frame
Percentage of Participant Who Were Non-Failures	A participant was considered as non-failure if the calculated DAS28 <=3.2 at all visits or if the calculated DAS28 >3.2, the increase of calculated DAS28 from randomization (Week 0): was <0.6 at all visit or was >=0.6 but <1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.	Week 48

Measure	Description	Time Frame
Time to Treatment Failure (TTF)	TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Glostrup Municipality		DK-2600	Denmark
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
25873634	Derived	van Vollenhoven RF, Ostergaard M, Leirisalo-Repo M, Uhlig T, Jansson M, Larsson E, Brock F, Franck-Larsson K. Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. Ann Rheum Dis. 2016 Jan;75(1):52-8. doi: 10.1136/annrheumdis-2014-205726. Epub 2015 Apr 14.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Etanercept 50 mg - Period 1	Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participant Who Were Non-Failures

A participant was considered as non-failure if the calculated DAS28 <=3.2 at all visits or if the calculated DAS28 >3.2, the increase of calculated DAS28 from randomization (Week 0): was <0.6 at all visit or was >=0.6 but <1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.

Modified intent-to-treat (m-ITT) analysis set included all randomized participants who received at least 1 dose of study medication after randomization and had at least 1 available evaluation after the first administration of study medication after randomization.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
OG002	Placebo - Period 2	Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Units	Counts
Participants	OG00023 OG00127 OG00223

Title

Denominators

Categories

Title	Measurements
	OG00052.2 OG00144.4 OG00213.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Analysis was performed using a generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.	GEE Model		0.007		Odds Ratio (OR)	7.17			2-Sided	95	1.72	29.82				No	Superiority or Other

Secondary

Time to Treatment Failure (TTF)

TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal.

m-ITT analysis set.

Posted

Median

95% Confidence Interval

weeks

Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2

Secondary

Percentage of Participants With Remission or Low Disease Activity (LDA)

Participants who had DAS28 less than or equal to (<=) 3.2 were considered in remission or LDA state.

m-ITT analysis set. Here, 'n' signifies participants evaluable for each time-point for each treatment arm, respectively.

Posted

Number

percentage of participants

Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State

Participants who had DAS28 <=3.2 were considered in remission or LDA state. Percentage of visits during which a participant was in remission or LDA state was calculated as number of visits in which participant was in remission or LDA divided by total number of visits multiplied by 100.

m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

percentage of visits

Randomization (Week 0) up to Week 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 implied low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and less than (<) 2.6=remission.

m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

units on a scale

Randomization (Week 0)

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2

Secondary

Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48

DAS28 calculated from SJC and PJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and <2.6=remission.

m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Least Squares Mean

Standard Error

units on a scale

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48

Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from randomization indicates an improvement.

m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.

Posted

Median

Full Range

tender joints

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48

Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from randomization indicates an improvement.

m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.

Posted

Median

Full Range

swollen joints

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48

PGA of disease activity was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 mm = extreme disease activity.

m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.

Posted

Median

Full Range

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48

Participants assessed the overall activity of their rheumatoid arthritis (RA) on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extreme disease activity.

m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.

Posted

Median

Full Range

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Participant General Health Visual Analog Scale (VAS) at Randomization

Participants answered "in general how would you rate your health over the last 2-3 weeks?" Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.

m-ITT analysis set.

Posted

Mean

Standard Deviation

Randomization (Week 0)

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48

Participants answered "in general how would you rate your health over the last 2-3 weeks?" Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.

m-ITT analysis set.

Posted

Least Squares Mean

Standard Error

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Participant Pain Visual Analog Scale (VAS) at Randomization

Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.

m-ITT analysis set.

Posted

Mean

Standard Deviation

Randomization (Week 0)

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48

Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.

m-ITT analysis set.

Posted

Least Squares Mean

Standard Error

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48

Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. The duration of morning stiffness was determined by asking the following questions: 1) Over the last 2 days, when did you wake in the morning? 2) Over the last 2 days, when were you able to resume your normal activities without stiffness? Increase in stiffness duration from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Posted

Median

Full Range

minutes

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A higher rate is consistent with inflammation.

Posted

Median

Full Range

mm/hour

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.

Posted

Median

Full Range

mg/L

Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48

mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at randomization. An increase in mTSS from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Posted

Median

Full Range

units on a scale

Randomization (Week 0), Week 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2

Secondary

Magnetic Resonance Imaging (MRI) Findings at Randomization

MRI of hand/wrist of dominant hand scored for signs of synovitis (S-score), bone edema(O-score), bone erosions (E-score) as per outcome measures in RA clinical trials (OMERACT). S-score:0(normal)-3(severe) for distal radioulnar,radiocarpal,intercarpal-carpometacarpal,second-fifth metacarpophalangeal joints, total score(TS)0-21, higher score(HS)=severe synovitis. O-score:0(no volume increment)-3(100% volume increment) in 23 hand/wrist joints, TS 0-69, HS=more edema. E-score:0(no volume occupied by erosion)-10(100% volume occupied by erosion) in 23 hand/wrist joints, TS 0-230, HS=more erosion.

m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

units on a scale

Randomization (Week 0)

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2

Secondary

Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12

MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. S-score: 0 (normal) to 3 (severe) for each of distal radioulnar, radiocarpal, intercarpal-carpometacarpal, second to fifth metacarpophalangeal joints; total score 0 to 21, higher score=severe synovitis.

m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Least Squares Mean

Standard Error

units on a scale

Randomization (Week 0), Week 12

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12

MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. O-score: 0 (no volume increment) to 3 (100% volume increment) in 23 hand/wrist joints; total score 0 to 69, higher scores=more edema. E-score: 0 (no volume occupied by erosion) to 10 (100% volume occupied by erosion) in 23 hand/wrist joints; total score 0 to 230, higher scores=more erosion.

m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Median

Full Range

units on a scale

Randomization (Week 0), Week 12

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.

Secondary

Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization

Percentage of participants who were treatment failure over 48 weeks as per potentially predictor variables (at randomization) are reported: number of swollen joints/tender joints, DAS28, PGA, PtGA, participant general health VAS, participant pain VAS, clinical disease activity index (CDAI), simplified disease activity index (SDAI), ESR (mm/hour), plasma CRP (mg/L), sensitive serum CRP (mg/L), anti- cyclic citrullinated peptide (anti CCP, units/mL), cartilage oligomeric matrix protein (COMP, units/liter), S-score, O-score, E-score, Joint space narrowing score, erosion score, and mTSS.

m-ITT analysis set.

Posted

Number

percentage of participants

Randomization (Week 0) up to Week 48

ID	Title	Description
OG000	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
OG001	Etanercept 25 mg - Period 2

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0007 affected91 at risk EG0016 affected23 at risk EG0028 affected27 at risk EG0032 affected23 at risk EG0048 affected43 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected91 at risk EG0016 affected23 at risk EG0023 affected27 at risk EG003
Bronchitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected23 at risk EG0021 affected27 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Influenza	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Laryngitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected91 at risk EG0013 affected23 at risk EG0021 affected27 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected23 at risk EG0023 affected27 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Adverse drug reaction	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Discomfort	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected23 at risk EG0021 affected27 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected23 at risk EG0022 affected27 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0023 affected27 at risk EG003
Rhinitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0021 affected27 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Erythema migrans	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Oral herpes	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Otitis externa	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Paronychia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Tooth infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Viral rhinitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Localised infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Skin infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Bacteriuria	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Borrelia infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Enterobiasis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Eye infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0021 affected27 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0021 affected27 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Rheumatoid nodule	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0023 affected27 at risk EG003
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Influenza like illness	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Injection site reaction	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Local swelling	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Chest discomfort	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0021 affected27 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0022 affected27 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Sigmoiditis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0013 affected23 at risk EG0021 affected27 at risk EG003
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Migraine	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Urinary tract disorder	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Cataract operation	Surgical and medical procedures	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Dental operation	Surgical and medical procedures	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Toe operation	Surgical and medical procedures	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Cataract	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Photokeratitis	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
C-reactive protein increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Red blood cell sedimentation rate increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0022 affected27 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Depression	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Benign neoplasm of eyelid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D007127	Immunoglobulin Constant Regions
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins
D018124	Receptors, Tumor Necrosis Factor
D018121	Receptors, Cytokine
D011971	Receptors, Immunologic
D011956	Receptors, Cell Surface
D008565	Membrane Proteins

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Etanercept 50 mg - Period 1	Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.	0	91	27	91
EG001	Etanercept 50 mg - Period 2	Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.	1	23	16	23
EG002	Etanercept 25 mg - Period 2	Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.	1	27	20	27
EG003	Placebo - Period 2	Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.	0	23	7	23
EG004	Etanercept 50 mg - Period 3	Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.	1	43	31	43

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Endometritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0021 affected27 at risk EG0030 affected23 at risk EG0040 affected43 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected23 at risk EG0020 affected27 at risk EG003
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected23 at risk EG0020 affected27 at risk EG003