Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)

Phase 3

Terminated

Interventions: Drug: Tabalumab Auto-Injector
Drug: Tabalumab Prefilled Syringe

Brief Summary: The purpose of this study is to evaluate the serum concentration of tabalumab after the administration using either prefilled syringe or auto-injector after the initial loading dose and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety extension.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Tabalumab Auto-Injector	Tabalumab Auto-Injector	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.
Tabalumab Prefilled Syringe	Tabalumab Prefilled Syringe	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set	Baseline, Week 12
Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index	Baseline, Week 12
Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level	Baseline, Week 12
Percentage of Participants Achieving ACR Response	Week 12
Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)	Week 12
Number of Operation Failures	Week 12
Number of Participants Developing Anti-Tabalumab Antibodies	Week 12
Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)	Baseline, Weeks 4 and 8

Locations (1): 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.
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Yaroslavl, Russian Federation