A Study of Glucocorticoid Use to Evaluate Systematic Meth... | NCT01219933

ID	Type	Description	Link
2010-019694-15

Label	Type	Description	Intervention Names
1	Experimental		Drug: methylprednisolone Drug: tocilizumab [RoActemra/Actemra]

Name	Type	Description	Arm Group Labels	Other Names
methylprednisolone	Drug	starting dose >/= 1 mg and \	1

Measure	Description	Time Frame
Median GC Dose Taken During the Noninterventional Phase	During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents.	V1 and V2 (up to 6 months after V1)
Number of Participants With GC Switches During the Noninterventional Phase	During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets.	V1 and V2 (up to 6 months after V1)
Type of GC Taken at the End of the Noninterventional Phase	During the noninterventional phase of the study participants received GC as prescribed by the physician.	V1 and V2 (up to 6 months after V1)
Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks	The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2.	Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)

Measure	Description	Time Frame
Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase	DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP 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 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

ID	Title	Description
FG000	Tocilizumab	Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) once every 4 weeks and methotrexate (MTX) 7.5 to 25 mg per week (mg/week; per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received an oral glucocorticoid (GC; no product/dose limitation) until low disease activity (LDA; defined as Disease Activity Score Based on 28-Joint Count and C-reactive protein [DAS28-CRP] less than or equal to [≤]3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to methylprednisolone (MP) tablets, by mouth (PO). MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be greater than or equal to [≥]1 mg and ≤20 mg per day [mg/day]), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment

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

Median GC Dose Taken During the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents.

Safety obs population; n (number) equals (=) number of participants analyzed for a given parameter at a specified timepoint

Posted

Median

Full Range

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG00068

Title

Denominators

Categories

Start dose V1 (n=68)

Title	Measurements
	OG0006(2 to 40)

Start dose (V1) for Interventional phase (n=50)

Title	Measurements
	OG0006(2 to 32)

Stop dose (V2; n=50)

Primary

Number of Participants With GC Switches During the Noninterventional Phase

During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets.

Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint

Posted

Number

participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP 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 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA.

Safety Obs Population

Posted

Number

percentage of participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts

Secondary

Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP 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 <2.6 = remission.

Safety Obs population

Posted

Number

percentage of participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants

Secondary

Percentage of Participants With Erosions During the NonInterventional Phase

In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Number

percentage of participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants

Secondary

Number of Erosions During the NonInterventional Phase

In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

erosions

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants

Secondary

Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Number

percentage of participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants

Secondary

Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase

Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Number

percentage of participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants

Secondary

Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

DAS28-CRP During the Noninterventional Phase

DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

DAS28-ESR During the Noninterventional Phase

DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

Clinical Disease Activity Index (CDAI) During the Noninterventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts

Secondary

Median Time Interval Between V1 and V2

The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months.

Safety Obs Population

Posted

Median

Full Range

months

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG000

Secondary

Median Dose of Tocilizumab During the Noninterventional Phase

Safety Obs Population

Posted

Median

Full Range

mg/kg

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase

The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events.

Safety Obs Population

Posted

Number

participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase

Safety Obs Population

Posted

Number

percentage of participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Able to Start the GC Reduction Phase at V3

All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC.

Safety Int (intervention) run-in: all participants eligible to enter the interventional phase at V2 and who had taken at least 1 dose of MP.

Posted

Number

95% Confidence Interval

percentage of participants

V3 (7 months)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants

Secondary

Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9

Safety Int run-in; only those participants who completed the study at V9 were included in the analysis.

Posted

Number

95% Confidence Interval

percentage of participants

V9 (24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9

Safety Int run-in; pnly those participants who completed the study at V9 were included in analysis.

Posted

Number

95% Confidence Interval

percentage of participants

V9 (24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG000

Secondary

Time-Averaged GC Dose Changes During the Interventional Phase

Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:

AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]

With Di=dosage at time Ti

It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9.

Safety Int run-in; only participants who completed the study were included in the analysis.

Posted

Mean

Standard Deviation

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts

Secondary

DAS28-CRP During the Interventional Phase

DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

HAQ-DI During the Interventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined.

Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase

Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined.

Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.

Posted

Mean

Standard Deviation

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

VAS for Pain (VAS-Pain) During the Interventional Phase

Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean.

Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.

Posted

Mean

Standard Deviation

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants

Secondary

SJC and TJC During the Interventional Phase

TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined.

Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

joints

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units

Secondary

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined.

Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Primary

Type of GC Taken at the End of the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician.

Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint

Posted

Number

percentage of participants

V1 and V2 (up to 6 months after V1)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts
Participants	OG000

Primary

Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks

The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2.

Intent-to-Treat (ITT) population: all participants included in the interventional GC reduction phase of the study.

Posted

Number

95% Confidence Interval

percentage of participants

Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts

Secondary

Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase

36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined.

Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

SF-36 Subscale Scores During the Interventional Phase

SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined.

ITT Population; n=number of participants analyzed for the given parameter at the specified time point.

Posted

Mean

Standard Deviation

units on a scale

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

CDAI Score During the Interventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined.

Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Units	Counts

Secondary

Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI

Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Number

percentage of participants

Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Secondary

Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP

DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP 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-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission.

Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.

Posted

Number

percentage of participants

Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

ID	Title	Description
OG000	Tocilizumab	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0006 affected68 at risk EG0013 affected43 at risk
Fatigue	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0004 affected68 at risk EG0010 affected43 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (16.0)	Non-systematic Assessment	EG0005 affected68 at risk EG0011 affected43 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0013 affected43 at risk
Oedema peripheral	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0013 affected43 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0013 affected43 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Palpitations	Cardiac disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0010 affected43 at risk
Otosalpingitis	Ear and labyrinth disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0011 affected43 at risk
Cataract	Eye disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Conjunctivitis	Eye disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0010 affected43 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0011 affected43 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Gastritis	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0010 affected43 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0010 affected43 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Vomiting	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected43 at risk
Asthenia	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Face oedema	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Pain	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0012 affected43 at risk
Pyrexia	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected43 at risk
Body tinea	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Influenza like illness	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Local swelling	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Arthritis infective	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Cellulitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Cystitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Gastroenteritis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Lung infection	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Pharyngitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Rhinitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Sinusitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Tinea pedis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Urinary tract infection	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Erysipelas	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Herpes virus infection	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Nasopharyngitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Bronchopneumonia	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Ear infection	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Infection	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Laryngitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0012 affected43 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Alanine aminotransferase increased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Blood bilirubin increased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Hepatic enzyme increased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Weight increased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected43 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0011 affected43 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0011 affected43 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Headache	Nervous system disorders	MedDRA (16.0)	Non-systematic Assessment	EG0003 affected68 at risk EG0010 affected43 at risk
Presyncope	Nervous system disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Dizziness	Nervous system disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Anxiety	Psychiatric disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0011 affected43 at risk
Depression	Psychiatric disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Insomnia	Psychiatric disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected43 at risk
Suicide attempt	Psychiatric disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Renal cyst	Renal and urinary disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0003 affected68 at risk EG0012 affected43 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected43 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0012 affected43 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected43 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 affected68 at risk EG0011 affected43 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0011 affected43 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Hip surgery	Surgical and medical procedures	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Hypertension	Vascular disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 affected68 at risk EG0010 affected43 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Hot flush	Vascular disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Phlebitis	Vascular disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Surgery	Surgical and medical procedures	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk
Rheumatoid vasculitis	Vascular disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 affected68 at risk EG0011 affected43 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Aalst		9300	Belgium

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
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Noninterventional Phase	Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week according to local standard of care and at the investigator's discretion (or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months.			4	68	36	68
EG001	Interventional Phase	All participants who maintained LDA from V2 to V3 were included in the interventional phase for reduction of GC. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.			1	43	26	43