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Clinical Trials/ACTRN12617001470381
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.

Dendright Pty Ltd0 sites40 target enrollmentStarted: October 18, 2017Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Withdrawn
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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