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

NCT ID: NCT01676701

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-08-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tabalumab Auto-Injector

Intervention Type: DRUG

Administered SC by auto-injector

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.

Group Type: EXPERIMENTAL

Tabalumab Prefilled Syringe

Intervention Type: DRUG

Administered SC by prefilled syringe

Interventions

Tabalumab Auto-Injector

Administered SC by auto-injector

Intervention Type: DRUG

Tabalumab Prefilled Syringe

Administered SC by prefilled syringe

Intervention Type: DRUG

Other Intervention Names

LY2127399; LY2127399

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Glendale, Arizona, United States

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Lewes, Delaware, United States

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DeBary, Florida, United States

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Tamarac, Florida, United States

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Indianapolis, Indiana, United States

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Prairie Village, Kansas, United States

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Lansing, Michigan, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Freehold, New Jersey, United States

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Philadelphia, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Spokane, Washington, United States

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Quilmes, , Argentina

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San Juan, , Argentina

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San Miguel de Tucumán, , Argentina

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Hostivice, , Czechia

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Plzen-Bory, , Czechia

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Prague, , Czechia

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Uherské Hradiště, , Czechia

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Zlín, , Czechia

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Elblag, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Ponce, , Puerto Rico

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San Juan, , Puerto Rico

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Santurce, , Puerto Rico

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Ulyanovsk, , Russia

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Yaroslavl, , Russia

Countries

United States; Argentina; Czechia; Poland; Puerto Rico; Russia

Other Identifiers

H9B-MC-BCEF

Identifier Type: OTHER

Identifier Source: secondary_id

14598

Identifier Type: -

Identifier Source: org_study_id