Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate.
- Conditions
- Rheumatoid ArthritisTherapeutic area: Diseases [C] - Immune System Diseases [C20]MedDRA version: 14.1Level: LLTClassification code 10042952Term: Systemic rheumatoid arthritisSystem Organ Class: 100000004859
- Registration Number
- EUCTR2012-001618-40-CZ
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
•Patients =18 years of age with diagnosis of adult-onset RA as defined by the 2010 RA classification and diagnosis of disease for at least 6 months prior to screening.
•At least 8 tender and swollen joints.
•Adnormal C-Reactive Protein (CRP) level or Erythrocyte Sedimentation rate (ESR) rate.
•Positive for Rheumatoid Factor (RF) and/or Anti-cyclic citrullinated peptide antibody (anti-CCP Ab).
•Regular use of MTX for at least 12 weeks and stable dose (10 to 25 mg/week) for at least 8 weeks prior to baseline.
•ACR functional class I, II, or III.
•Able and willing to inject study drug by themselves (or have an assistant who will inject study drug) and able and willing to complete all study procedures.
•Able and willing to have blood drawn for PK sampling per protocol (PP).
•Female patients of childbearing potential must test negative for pregnancy at the time of enrollment and agree to use 2 reliable methods of birth control or remain abstinent during the study or for at least 8 weeks following the last dose of study drug, whichever is longer, or, must be a female of non-childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
•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 intra-articular) corticosteroid within 6 weeks of baseline.
•Have previously discontinued treatment with a DMARD or a novel drug that interrupts cytokine signaling (eg, JAK inhibitors) due to insufficient efficacy.
•Previous severe reaction to any biologic therapy.
•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 other than MTX, hydroxychloroquine, chloroquine, or sulfasalazine, in the 8 weeks prior to baseline.
•Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil.
•Surgical treatment within 60 days prior to baseline of a joint that is to be assessed in the study or will require such treatment during the study.
•Any major surgery within 60 days prior to baseline or required during the study.
•Active fibromyalgia or diagnosis of any systemic inflammatory condition other than RA. Patients with secondary Sjögren's syndrome are not excluded.
•Any malignancy within the past 5 years, except for cervical carcinoma in situ, that has been resected with no evidence of recurrence or metastatic disease or basal cell or squamous epithelial skin cancers that were completely resected and have no evidence of recurrence for at least 3 years.
•Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or neuropsychiatric disorders, or abnormal laboratory values at screening
•ECG abnormalities that are considered clinically significant
•Live vaccine within 12 weeks prior to baseline or intend to receive a live vaccine during the course of the study.
•Evidence of or positive test for hepatitis B (positive for hepatitis B surface antigen [HBsAg+]) OR are positive for hepatitis B core antibody (HBcAb+) and negative for hepatitis B surface antibody(HBsAb-) at screening.
•Hepatitis C virus (HCV; positive for anti–hepatitis C antibody with confirmed presence of HCV.)
•Positive for human immunodeficiency virus (HIV; positive for human HIV antibodies).
•Serious infection (for example, pneumonia or cellulitis) within 3 months of baseline or had serious bone or joint infections within 6 months of baseline or are immunocompromised to an extent such that participation in the study would pose an unacceptable risk to the patient.
•An active or recent infection (including symptomatic herpes zoster or herpes simplex) within 30 days of screening (Visit 1) or between Visit 1 and Visit 2.
•Evidence of active or latent TB as documented by a PPD test with an induration =5 mm between 2 and 3 days after application (regardless of vaccination history, medical history, and chest X-ray at screening). In locations where the QuantiFERON®-TB Gold test is available, it may be used instead of the PPD test.
•Known hypogammaglobulinemia or a screening serum immunoglobulin G (IgG), immunoglobulin M (IgM), or immunoglobulin A (IgA) concentration less than the lower limit of normal.
•Significant hematological abnormalities, including hemoglobin <8.5 g/dL, total platelet count <100,000 cells/µL, total white blood cell (WBC) count <3000 cells
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method