Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumato... | NCT00634933

NCT00634933

ID	Type	Description	Link
B2051001

Status Module

Sponsor/Collaborators Module

Name	Class
Trubion Pharmaceuticals/Emergent BioSolutions Inc.	UNKNOWN

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Consists of Arms 1a and 1b	Drug: TRU-015 Drug: Methylprednisolone Drug: Prednisone
Arm 2	Experimental	Consists of Arms 2a and 2b	Drug: TRU-015 Drug: Methylprednisolone Drug: Prednisone
Arm 3	Placebo Comparator	Consists of Arms 3a and 3b.	Drug: TRU-015 Drug: Methylprednisolone Drug: Prednisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TRU-015	Drug	IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24	ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).	Week 24

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response	ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35294-7201	United States
Pfizer Investigational Site

References Module

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

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo infusion, matched to TRU-015 (800 milligram [mg]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG00074 subjects
FG00175 subjects
FG00273 subjects
FG0030 subjects
FG0040 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
BG001	TRU-015 Single Dose	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
BG002	TRU-015 Induction Dose	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00016.2 OG00129.3 OG00227.4

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 OG001	A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.	Cochran-Mantel-Haenszel		0.061						2-Sided							No	Superiority or Other
OG000 OG002	A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.

Secondary

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Posted

Number

percentage of participants

Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 20 were not analyzed because of early termination of the study.

Posted

Number

percentage of participants

Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.

Posted

Number

percentage of participants

Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

Number of Tender Joints

The 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.

Posted

Mean

Standard Deviation

tender joints

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001

Secondary

Number of Swollen Joints

The 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.

Posted

Mean

Standard Deviation

swollen joints

Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001

Secondary

Duration of Morning Stiffness

Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Posted

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001

Secondary

Visual Analogue Scale for Pain (VAS-pain)

100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.

Posted

Mean

Standard Deviation

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001	TRU-015 Single Dose

Secondary

Physician Global Assessment (PGA) of Disease Activity

Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001	TRU-015 Single Dose

Secondary

Patient Global Assessment (PtGA) of Disease Activity

Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001	TRU-015 Single Dose

Secondary

General Health Visual Analog Scale (VAS)

100 mm line (VAS) marked by participant. Participants were asked, "How do you feel concerning your arthritis?" Total possible score range, 0 mm = very well to 100 mm = extremely bad.

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Posted

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001	TRU-015 Single Dose	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

Health Assessment Questionnaire Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

Disease Activity Score Based on 28-joints Count (DAS28)

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 participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

36-Item Short-Form Health Survey (SF-36)

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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Posted

Baseline, Week 12, 24, 36, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001	TRU-015 Single Dose

Secondary

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state.

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Posted

Baseline, Week 12, 24, 36, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Posted

Baseline, Week 12, 24, 36, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
OG001	TRU-015 Single Dose

Secondary

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was 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-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Posted

Baseline, Week 12, 24, 36, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score

WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Posted

Baseline, Week 12, 24, 36, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Secondary

Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.

Posted

Number

percentage of participants

Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ID	Title	Description
OG000	Placebo	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo (Part A)	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.	7	74	25	74
EG001	TRU-015 Single Dose (Part A)	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-SD in the Part B of the study.	4	75	27	75
EG002	TRU-015 Induction Dose (Part A)	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-ID in the Part B of the study.	7	73	25	73
EG003	TRU-015 Single Dose (Part B)	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	2	56	22	56
EG004	TRU-015 Induction Dose (Part B)	Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	2	55	12	55
EG005	Placebo/TRU-015 Single Dose (Part B)	TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 800 mg, IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	0	31	18	31
EG006	Placebo/TRU-015 Induction Dose (Part B)	TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.	0	32	14	32

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG0030 affected56 at risk EG0040 affected55 at risk EG0050 affected31 at risk EG0060 affected32 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0021 affected73 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0011 affected75 at risk EG0020 affected73 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0011 affected75 at risk EG0020 affected73 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0011 affected75 at risk EG0020 affected73 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0011 affected75 at risk EG0020 affected73 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0022 affected73 at risk EG003
Influenza	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Pneumonia	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Appendicitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0021 affected73 at risk EG003
Joint sprain	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0021 affected73 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0011 affected75 at risk EG0021 affected73 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0021 affected73 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected74 at risk EG0011 affected75 at risk EG0020 affected73 at risk EG0030 affected56 at risk EG0040 affected55 at risk EG0051 affected31 at risk EG0062 affected32 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected74 at risk EG0013 affected75 at risk EG0024 affected73 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected74 at risk EG0010 affected75 at risk EG0024 affected73 at risk EG003
Infusion related reaction	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0004 affected74 at risk EG0012 affected75 at risk EG0020 affected73 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0014 affected75 at risk EG0022 affected73 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0005 affected74 at risk EG0016 affected75 at risk EG0025 affected73 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0010 affected75 at risk EG0020 affected73 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0007 affected74 at risk EG0014 affected75 at risk EG0026 affected73 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected74 at risk EG0015 affected75 at risk EG0020 affected73 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected74 at risk EG0017 affected75 at risk EG0025 affected73 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected74 at risk EG0014 affected75 at risk EG00210 affected73 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected74 at risk EG0011 affected75 at risk EG0025 affected73 at risk EG003

As the results of the primary analysis did not meet the predefined efficacy criteria, the development of TRU-015 was discontinued.

Certain Agreements

ID	Term
D001172	Arthritis, Rheumatoid
D009043	Motor Activity
D001168	Arthritis

Ancestor Terms

ID	Term
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
D001519	Behavior

ID	Term
C540931	TRU-015 protein
D008775	Methylprednisolone
D011241	Prednisone

TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0041 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0041 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0041 affected55 at risk

EG0052 affected31 at risk

EG0060 affected32 at risk

EG0041 affected55 at risk

EG0051 affected31 at risk

EG0062 affected32 at risk

EG0041 affected55 at risk

EG0052 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0043 affected55 at risk

EG0056 affected31 at risk

EG0064 affected32 at risk

EG0040 affected55 at risk

EG0052 affected31 at risk

EG0060 affected32 at risk

EG0043 affected55 at risk

EG0051 affected31 at risk

EG0061 affected32 at risk

EG0041 affected55 at risk

EG0052 affected31 at risk

EG0063 affected32 at risk

EG0040 affected55 at risk

EG0053 affected31 at risk

EG0061 affected32 at risk

EG0043 affected55 at risk

EG0051 affected31 at risk

EG0060 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0062 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

EG0041 affected55 at risk

EG0051 affected31 at risk

EG0063 affected32 at risk

EG0040 affected55 at risk

EG0051 affected31 at risk

EG0063 affected32 at risk

EG0042 affected55 at risk

EG0053 affected31 at risk

EG0062 affected32 at risk

EG0040 affected55 at risk

EG0050 affected31 at risk

EG0060 affected32 at risk

ID	Term
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols