A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG

• Conditions: Rheumatoid arthritis; MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2008-001105-42-AT
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Ambulatory males or females between the ages of 18 and 75 years, inclusive.
•Women must not be pregnant, breastfeeding, or at risk to become pregnant during study participation and must have a negative pregnancy test. Women of childbearing potential must use a medically permitted form of contraception during the whole study, and for at least 8 weeks after the last injection of study drug. Methods of contraception considered acceptable are oral contraceptives, contraceptive patch, intrauterine device (IUD), vaginal ring, diaphragm, or condom with contraceptive gel.
•Diagnosis of RA according to the ARA 1987 Revised Criteria for the Classification of RA (Arnett et al. 1988).
•Have either had an insufficient response, in the opinion of the investigator, to at least 3 months of treatment with at least 1 TNFa inhibitor therapy at approved doses (stopped due to insufficient efficacy) OR have been intolerant of such treatment regardless of treatment duration. Patients must have stopped etanercept >28 days, abatacept >90 days, anakinra >7 days, and infliximab or adalimumab >56 days, or any other biologic DMARD >5 half-lives prior to baseline.
•Regular use of methotrexate for 12 weeks, and at a stable dose between 7.5 and 25 mg/wk, inclusive, for at least 8 weeks prior to baseline.
•Have either history of, or current, positive rheumatoid factor (RF) test OR negative RF test and a history of, or current positive anti-cyclic citrullinated peptide antibody (anti-CCP).
•ACR functional class I, II, or III.
•Have active RA defined as at least 5/28 swollen and at least 5/28 tender joints based on the joint count specified.
•Have a screening CRP of at least the ULN or a screening ESR of at least 28 mm/hr.
•Clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations as judged by the investigator.
•Venous access sufficient to allow study drug administration and blood sampling as per the protocol.
•Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
•Have given written informed consent approved by Lilly or its designee and the ethical review board (ERB) governing the site.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Had symptomatic herpes zoster within 3 months of enrollment.
• Evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
• Evidence of hepatitis C and/or positive hepatitis C antibody.
• Evidence of hepatitis B and/or positive hepatitis B surface antigen.
• Evidence or suspicion of active tuberculosis (TB) by medical history, physical examination, and/or screening chest radiograph.
• At the time of screening, a positive PPD test for TB. For the purpose of this study, a positive test is defined as induration =10 mm, between approximately 2 and 3 days after test application. Exceptions to this criterion include patients with a history of a positive PPD who have been treated with isoniazid (INH) (documented) for at least 6 months, or patients with a previous diagnosis of TB who have received appropriate treatment (documented) and have not been re-exposed to TB since their treatment was completed.
• Have had other recent or ongoing infection that in the opinion of the investigator poses an unacceptable risk to participate in the study.
• Exposed to a live vaccine within 3 months of enrollment or expected to need/receive a live vaccine during the course of the study.
• Have significant hematological abnormalities, including haemoglobin less than 8.0 g/dL, total platelet count less than 100,000/µL, total white blood cell (WBC) count less than 3000/µL, neutrophil count less than 1000/µL, or lymphocyte count less than 200 cells/µL.
• Have a screening serum creatinine >2.0 mg/dL.
• Have known hypogammaglobulinemia or a serum IgG, IgM, or IgA concentration less than the lower limit of normal.
• Have any history of chronic liver disease or with serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >1.2x the upper limit of normal. The AST and ALT may be repeated once within a week if the initial result exceeds this limit, and the lesser value accepted if it meets this criterion.
• Blood donation of more than 500 mL within the last month.
• Women with a positive pregnancy test or women who are lactating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified