Evaluation of Tabalumab Using Auto-Injector or Prefilled... | NCT01676701

NCT01676701

ID	Type	Description	Link
H9B-MC-BCEF	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

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
Tabalumab Auto-Injector	Experimental	Tabalumab 180 milligram (mg) loading dose administered using auto-injectors at Week 0 as 2 subcutaneous (SC) injections (90 mg each), followed by a 90 mg SC injection every 2 weeks (Q2W) up to Week 12.	Drug: Tabalumab Auto-Injector
Tabalumab Prefilled Syringe	Experimental	Tabalumab 180 mg loading dose administered using prefilled syringes at Week 0 as 2 SC injections (90 mg each), followed by a 90 mg SC injection Q2W up to Week 12.	Drug: Tabalumab Prefilled Syringe

Name	Type	Description	Arm Group Labels	Other Names
Tabalumab Auto-Injector	Drug	Administered SC by auto-injector	Tabalumab Auto-Injector

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose		Days 4, 7, 9, 11, and 14 after loading dose administered
PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]		Days 4, 7, 9, 11, and 14 after loading dose administered

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set		Baseline, Week 12
Percentage of Participants Achieving ACR Response		Week 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ambulatory males or females ≥18 years of age
Diagnosis of adult-onset RA
Active RA (at least 8/68 tender and at least 8/66 swollen joints)
Screening C-reactive protein (CRP) >1.2 times the upper limit of normal (ULN) or a screening erythrocyte sedimentation rate (ESR) >28 millimeters per hour (mm/hr)
Documented history of, or current, positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) test
Regular use of methotrexate (MTX) for at least 12 weeks and stable dose (10 to 25 mg/week) for at least 8 weeks prior to baseline
American College of Rheumatology (ACR) functional class I, II, or III
Able and willing to inject tabalumab by themselves (or have an assistant who will inject tabalumab) and able and willing to complete all study procedures
Able and willing to have blood drawn for pharmacokinetic (PK) sampling

Exclusion Criteria:

Use of oral corticosteroids at average daily doses of >10 milligrams per day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline
Injection of any parenteral (including intraarticular) corticosteroid within 6 weeks of baseline
Have previously discontinued treatment with a biologic disease-modifying antirheumatic drug (DMARD) or a novel drug that interrupts cytokine signaling [for example, Janus kinase (JAK) inhibitors] due to insufficient efficacy
Participants who had discontinued biologic DMARDS for reasons other than efficacy will not be excluded but must have done so prior to baseline
Participants who discontinued a JAK inhibitor for lack of efficacy
Participants who discontinued a JAK inhibitor for reasons other than efficacy will not be excluded, but must have done so prior to baseline for 21 days
Previous severe reaction to any biologic therapy that, in the opinion of the Investigator, would pose an unacceptable risk to the participant if participating in the study
Have had an inadequate response to treatment with 3 or more of the following DMARDs prescribed alone or in combination at approved doses for a minimum of 90 days: leflunomide, azathioprine, cyclosporine, and/or sulfasalazine
Use of other DMARDs (for example, gold salts, cyclosporin, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine, chloroquine, or sulfasalazine, or the use of a JAK inhibitor in the 8 weeks prior to baseline

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Glendale	Arizona	85304

References Module

No data available

No data is available for this block.

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	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).
FG001

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

Randomized participants who received at least 1 dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
BG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
BG002	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, Customized

Number

participants

Title

Denominators

Categories

43.3 to 65.4 years

Title	Measurements
	BG0004 BG0014 BG0028

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0004 BG0014 BG002

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

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Days 4, 7, 9, 11, and 14 after loading dose administered

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG0000 OG0010

Primary

PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Days 4, 7, 9, 11, and 14 after loading dose administered

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Baseline, Week 12

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving ACR Response

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Week 12

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Baseline, Week 12

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Baseline, Week 12

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Week 12

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Secondary

Number of Participants Developing Anti-Tabalumab Antibodies

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Week 12

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Secondary

Number of Operation Failures

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Week 12

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Secondary

Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)

No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.

Posted

Baseline, Weeks 4 and 8

ID	Title	Description
OG000	Tabalumab Auto-Injector	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
OG001	Tabalumab Prefilled Syringe	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tabalumab Auto-Injector (Treatment Period)	Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).	4	0	4
EG001	Tabalumab Auto-Injector (Post Treatment Follow-Up Period)	No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Auto-Injector treatment arm.	4	1	4
EG002	Tabalumab Prefilled Syringe (Treatment Period)	Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).	4	0	4
EG003	Tabalumab Prefilled Syringe (Post Treatment Follow-Up Period)	No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Prefilled Syringe treatment arm.	4	0	4

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Gastric Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0000 affected4 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG0030 affected4 at risk

Due to early termination of the trial, no participant had outcome measure data analyzed. Participants who received study treatment had disposition, demographic, and adverse event data reported.

Certain Agreements

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

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
C575974	tabalumab