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

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ClinicalTrials.gov Identifier: NCT01676701
Recruitment Status : Terminated (Insufficient efficacy observed in study BCDM(NCT01198002) and BCDV(NCT01202773))
First Posted : August 31, 2012
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Tabalumab Auto-Injector Drug: Tabalumab Prefilled Syringe Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: Tabalumab Auto-Injector
Administered SC by auto-injector
Other Name: LY2127399
Experimental: 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.
Drug: Tabalumab Prefilled Syringe
Administered SC by prefilled syringe
Other Name: LY2127399



Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose [ Time Frame: Days 4, 7, 9, 11, and 14 after loading dose administered ]
  2. 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 Outcome Measures :
  1. Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set [ Time Frame: Baseline, Week 12 ]
  2. Percentage of Participants Achieving ACR Response [ Time Frame: Week 12 ]
  3. Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index [ Time Frame: Baseline, Week 12 ]
  4. 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 ]
  5. Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28) [ Time Frame: Week 12 ]
  6. Number of Participants Developing Anti-Tabalumab Antibodies [ Time Frame: Week 12 ]
  7. Number of Operation Failures [ Time Frame: Week 12 ]
  8. Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ) [ Time Frame: Baseline, Weeks 4 and 8 ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676701


  Show 37 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01676701     History of Changes
Other Study ID Numbers: 14598
H9B-MC-BCEF ( Other Identifier: Eli Lilly and Company )
First Posted: August 31, 2012    Key Record Dates
Results First Posted: April 26, 2018
Last Update Posted: April 26, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs