A randomised, double-blind, placebo controlled, multicentre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis.
- Conditions
- rheumatism10003816
- Registration Number
- NL-OMON32036
- Lead Sponsor
- Merck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
The trial will enrol male and female subjects 18 years of age at the time of Informed Consent who have rheumatoid arthritis satisfying American College of Rheumatology criteria and a disease history of at least 12 months. Subjects must have active disease; defined by 8 swollen joints (out of 66), 8 tender joints (out of 68) and CRP 6 mg/L or ESR 28 mm/h. Subjects must have received previous treatment with rituximab and must be candidates for re-treatment
with rituximab: i.e. they must have a documented response after an observation period of at least 16 weeks from initiation of treatment to a previous course of rituximab treatment given at least 24 weeks before SD1 and they must have significant residual active disease after previous rituximab treatment or clinical deterioration after initial response (defined by satisfying the above criteria for active disease).
Female subjects of childbearing potential must be willing to avoid pregnancy by using an
adequate method of contraception for four weeks before SD1, during the treatment period and
for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test
at the screening visit and at SD1.
Main exclusion criteria are:
* Neurological disease.
* Inflammatory joint disease other than RA.
* Any contraindication to rituximab as per national label.
* Known presence of human anti-chimeric antibodies (HACA) to rituximab.
* Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or
methotrexate dose regimen >25 mg/week.
* Participation in any interventional clinical trial within 1 month before SD1 (or within
5 half-lives of the investigated compound before SD1, whichever is longer).
* Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing
regimen within 28 days before SD1.
* Active or latent tuberculosis within the year before screening or major infection requiring
hospitalisation or intravenous anti-infectives within 28 days before SD1.
* Serum IgG below 6 g/L.
* Known hypersensitivity to atacicept or to any of the components of the formulated
atacicept.
* Known hypersensitivity to rituximab, to any of the components of the formulated
rituximab or to murine proteins.
* Breastfeeding or pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints:<br /><br>* Nature, incidence and severity of adverse events (AEs); in particular,<br /><br>proportion of<br /><br>subjects with treatment-emergent infection-related AEs and proportion of<br /><br>subjects with<br /><br>serious infections.<br /><br>* Proportion of subjects who develop IgG <3 g/L.<br /><br>* Changes and abnormalities in vital signs and routine safety laboratory<br /><br>parameters.<br /><br>* Changes over time in vaccine immunisation status, assessed through<br /><br>anti-tetanus<br /><br>toxoid, anti-pneumococcus and anti-diphtheria toxoid antibody titres.</p><br>
- Secondary Outcome Measures
Name Time Method