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

Phase 3TerminatedNCT01676701

Eli Lilly and Company8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

Tabalumab Auto-InjectorDRUG

Administered SC by auto-injector

Tabalumab Prefilled SyringeDRUG

Administered SC by prefilled syringe

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (37)

Outcomes

Primary Outcomes

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

Time frame: 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)]

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

Secondary Outcomes

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

Time frame: Baseline, Week 12

Percentage of Participants Achieving ACR Response

Time frame: Week 12

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

Time frame: 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

Time frame: Baseline, Week 12

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

Time frame: Week 12

Number of Participants Developing Anti-Tabalumab Antibodies

Time frame: Week 12

Number of Operation Failures

Time frame: Week 12

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

Data from ClinicalTrials.gov

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