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



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/28/2018
Start Date:September 2012
End Date:August 2013

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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

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.


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
We found this trial at
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