A phase I clinical trial to assess the safety and induction of antigen-specific tolerance of autologous modified dendritic cells exposed to citrullinated peptides (Rheumavax) in patients with rheumatoid arthritis

niquest0 sites18 target enrollmentMay 10, 2010

Overview

No summary available.

Registry

who.int

Start Date

May 10, 2010

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niquest

•1\. Age 18\-75 years
•2\. Either sex. It is anticipated that the male: female ratio will be approximately 4:6 for due to the female preponderance with Rheumatoid Arthritis (RA)
•3\. Subjects who are willing and able to participate in the study for 6 months and from whom written informed consent has been obtained.
•4\. Diagnosis of definite RA by American College of Rheumatology criteria with symptoms for at least 3 months
•5\. In female patients of child\-bearing potential, safe contraceptive measures must be used
•6\. Blood glucose, routine hematology, creatinine, bilirubin and liver function tests within normal limits at entry
•7\. Must be receiving \<10mg/day of prednisone as part of their drug treatment. Patients must have had RA diagnosed and treated by a rheumatologist. Acceptable disease modifying treatment (either as monotherapy or combination therapy) includes methotrexate, salazopyrin, hydroxychloroquine, gold injections, leflunomide, or biologics (etanercept, infliximab, humira or anakinra). Anti\-inflammatory medications and local corticosteroid injections are also permissible.
•8\. Demonstrated anti\-CCP antibodies. Rheumatoid factor positive or negative. human leukocyte antigen (HLA)\-DR shared epitope positive (HLA\-DRB1\*0401, 0404, 0405, 0408, 01, 1001, 1401, 1402, 09\)

•1\. Any malignancy
•2\. History or family history of atopy: eczema, asthma, nasal polyps or allergic rhinitis
•3\. Positive allergen reactivity (RAST) test
•4\. Serious infection within the past 28 days that has not adequately responded to therapy
•5\. Receipt of any live attenuated vaccines within 4 weeks of study entry.
•6\. Major surgery within the past 28 days
•7\. Significant cardiovascular, renal, liver, neurological or skin disease
•8\. Females who are pregnant or lactating or who expect to become pregnant within the duration of the study, or who refuse to take contraceptives for the duration of the study
•9\. Positive serology for Human Immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV)
•10\. \>10 mg prednisone daily