A clinical study to investigate the safety of DEN-181 in rheumatoid arthritis patients

Phase 1

• Conditions: Rheumatoid Arthritis; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12617001482358
• Lead Sponsor: Dendright Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-19
• Study Completion: 2019-01-17
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

The criteria for entry into the study are:
1. Diagnosis of rheumatoid arthritis made by a rheumatologist;
2. HLA-DRB1*0401+, HLA-DRB1*0101+ or HLA-DRB1*0401+HLA-DRB1*0101+ heterozygotes, homozygotes or compound heterozygotes; and ACPA+ (anti-CCP2>6);
3. Treatment with MTX at the same dose for at least 4 weeks prior to planned start of trial treatment;
4. Age 18-75 years (male or female) inclusive;
5. Patients must be informed of the investigational nature of this study and give voluntary written informed consent in accordance with the institutional and hospital guidelines;
6. With or without swollen joints;
7. Male or Female. Females of child-bearing potential must agree to use two effective forms of contraception from enrolment to completion of the study;
8. Blood glucose, CBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT not greater than 1.5 times out of normal range at entry and clinically insignificant in the opinion of the investigator;
9. Patients agree to forego vaccinations during the course of the study;

Exclusion Criteria

The criteria for exclusion from the study are:
1. Malignancy;
2. An active inflammatory disease other than RA;
3. Currently receiving or have received treatment with >10mg prednisone daily within the last 2 weeks prior to screening;
4. Current or recent treatment (< 2 weeks prior) with any disease-modifying anti- rheumatic drugs other than methotrexate;
5. Serious infection requiring hospitalization within last 28 days;
6. Receipt of any live attenuated vaccines within 4 weeks prior to entry;
7. Major surgery within last 28 days;
8. Significant cardiovascular, renal, liver, neurological or skin disease;
9. Positive serology for HIV or infection with HBV or HCV;
10. Treatment with cytotoxic or immunomodulatory therapies such as radiotherapy, cyclophosphamide, mycophenolate, tacrolimus, PUVA, acitretin, cyclosporine or azathioprine;
11. Any known or suspected allergies to the study drug or its constituents including egg products;
12. Inadequate venous access to allow collection of blood samples;
13. History of drug or alcohol abuse;
14. Participation in another clinical study;
15. 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