Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: August 29, 2012
Last updated: January 7, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tabalumab Auto-Injector
Drug: Tabalumab Prefilled Syringe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics (PK): Maximum serum concentration (Cmax) of tabalumab after loading dose [ Time Frame: Day 0 to 14 after loading dose ] [ Designated as safety issue: No ]
  • PK: Area Under the Concentration Time Curve from time 0 to 14 days (AUC 0-14) of tabalumab after loading dose [ Time Frame: Day 0 to 14 after loading dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants achieving American College of Rheumatology (ACR) Response Rates [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants achieving European League Against Rheumatism Responder Index based on the 28-joint count (EULAR-28) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage Change from Baseline to 12 Week Endpoint in American College of Rheumatology (ACR-N) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 12 Week Endpoint in ACR Core Set [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 12 Week Endpoint in Disease Activity Score based on a 28-joint count and C-reactive protein level (DAS28-CRP) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Number of Operation Failures [ Time Frame: Baseline through 12 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants Developing Anti-tabalumab Antibodies [ Time Frame: Baseline up to 52 Weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ) for the Auto-Injector [ Time Frame: Baseline up to 8 Weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 180 milligram (mg) given as two subcutaneous (SC) injections each of 90 mg followed by 90 mg SC injections every two weeks.
Drug: Tabalumab Auto-Injector
Administered SC by auto-injector
Other Name: LY2127399
Experimental: Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 180 mg given as two SC injections each of 90 mg followed by 90 mg SC injections every two weeks.
Drug: Tabalumab Prefilled Syringe
Administered SC by prefilled syringe
Other Name: LY2127399


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 >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 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 (eg, 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 (eg, 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 and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01676701

  Show 37 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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
  More Information

Responsible Party: Eli Lilly and Company Identifier: NCT01676701     History of Changes
Other Study ID Numbers: 14598  H9B-MC-BCEF 
Study First Received: August 29, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on December 06, 2016