A clinical study to investigate the safety of multiple doses of DEN-181 in rheumatoid arthritis patients
- Conditions
- Rheumatoid ArthritisInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12617001470381
- Lead Sponsor
- Dendright Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 40
Diagnosis of RA made by a rheumatologist;
HLA-DRB1*0401+, HLA-DRB1*0101+ or HLA-DRB1*0401+HLADRB1*0101+ heterozygotes, homozygotes or compound heterozygotes and ACPA+;
Treatment with MTX at the same dose for at least 4 weeks prior to planned start of trial treatment;
Age 18-75 years, inclusive;
Male or female. Females of child-bearing potential must agree to use two effective forms of contraception from enrolment to completion of the study;
Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines;
Blood glucose, CBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT not greater than 1.5 x out of normal laboratory ranges at entry and clinically insignificant in opinion of investigator;
Patients agree to forego vaccinations during the course of the study.
Malignancy;
An active inflammatory disease other than RA;
Currently receiving or have received treatment with >10mg prednisone daily within the last 2 weeks prior to screening;
Current or recent treatment (< 2 weeks prior) with any diseasemodifying anti-rheumatic drugs (DMARDS) other than MTX;
Serious infection requiring hospitalisation within last 28 days;
Receipt of any live attenuated vaccines within 4 weeks prior to entry;
Major surgery within last 28 days;
Significant cardiovascular, renal, liver, neurological or skin disease;
Positive serology for HIV, or infection with HBV or HCV;
Current treatment with cytotoxic or immunomodulatory therapies such as radiotherapy, cyclophosphamide, mycophenolate, tacrolimus, PUVA, acitretin cyclosporine or azathioprine;
Any known or suspected allergies to the study drug or its constituents including egg products;
Inadequate venous access to allow collection of blood samples;
History of drug or alcohol abuse;
Participation in any other clinical trial;
If, in the opinion of the PI, the subject appears not to be able to perform the needed responsibilities of participation in the clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical safety observations including changes in: <br>Vital signs, Symptom directed physical examination, Adverse events (graded according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03), Laboratory abnormalities (Haematology including ESR and Clinical chemistry including CRP in serum samples), Urinalysis<br>[For the 56 day study period.<br>Assessment of primary outcomes will be conducted Day 1, 8 , 15 and 29 and at day 57 (exit evaluation).]
- Secondary Outcome Measures
Name Time Method Proportion and total number of naïve, effector and regulatory T-cells by flow cytometry (composite outcome).<br><br>[Assessment of the proportion and total number of naïve, effector and regulatory T-cells will be conducted on study day 1, 8, and 29.<br><br>];Determination of the concentration of calcitriol in plasma samples.[Assessment of plasma calcitrol concentration will be conducted on day 1, 8 and 15.];Mean changes in DAS28CRPv4 (Disease Activity Score 28 including CRP assessment 4 variable calculation) scoring system.[Assessment of changes in DAS28CRPv4 scoring system will be conducted on day 1, 8, 15, 29, 57.];Phenotype of naïve, effector and regulatory T-cells by flow cytometry.<br>[Assessment of the phenotype of naïve, effector and regulatory T-cells will be conducted on study day 1, 8, and 29.]