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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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 Design
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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


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Contacts and Locations
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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


Locations
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United States, Arizona
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.
Glendale, Arizona, United States, 85304
United States, Delaware
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Lewes, Delaware, United States, 19958
United States, Florida
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DeBary, Florida, United States, 32713
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Tamarac, Florida, United States, 33321
United States, Indiana
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Indianapolis, Indiana, United States, 46260
United States, Kansas
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Prairie Village, Kansas, United States, 66206
United States, Michigan
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Lansing, Michigan, United States, 48910
United States, Missouri
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Saint Louis, Missouri, United States, 63141
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Springfield, Missouri, United States, 68507
United States, Nevada
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Las Vegas, Nevada, United States, 89128
United States, New Jersey
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Freehold, New Jersey, United States, 07728
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19152
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Wyomissing, Pennsylvania, United States, 19610
United States, Washington
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Spokane, Washington, United States, 99204
Argentina
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Buenos Aires, Argentina, C1015ABO
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Córdoba, Argentina, 5000
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Quilmes, Argentina, B1878DVC
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San Juan, Argentina, 5400
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Tucuman, Argentina, 4000
Czechia
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Hostivice, Czechia, 253-01
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Plzen-Bory, Czechia, 305 99
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Prague, Czechia, 140 59
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Uherske Hradiste, Czechia, 686 01
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Zlin, Czechia, 760 01
Poland
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Bialystok, Poland, 15-351
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Bydgoszcz, Poland, 85-168
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Elblag, Poland, 82300
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Lublin, Poland, 20-607
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Poznan, Poland, 60-218
Puerto Rico
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Ponce, Puerto Rico, 00716
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San Juan, Puerto Rico, 00918
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Santurce, Puerto Rico, 00909
Russian Federation
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Moscow, Russian Federation, 119435
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Saint Petersburg, Russian Federation, 194291
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Saratov, Russian Federation, 410026
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Ulyanovsk, Russian Federation, 432063
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Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01676701    
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:
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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