ACTRN12617001470381WithdrawnPhase 1
A Phase I, randomised, double-blind, placebo-controlled, single centre, multiple-dose ranging study to investigate the safety, tolerability, and pharmacodynamics of subcutaneously administered DEN-181 in adult patients with ACPA+ rheumatoid arthritis on stable treatment with methotrexate.
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Dendright Pty Ltd
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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