Rheumatoid arthritis Level: PT Classification code 10039073
Conditions
Interventions
Product Name: AD 452 4.5 mg Tablet
Pharmaceutical Form: Tablet
CAS Number: 51742-86-0
Current Sponsor code: AD 452
Other descriptive name: (+) erythromefloquine
Concentration unit: mg milligram(s)
Con
Sponsors
Arakis Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Aged 18 - 75 3. Documented diagnosis of rheumatoid arthritis (RA) ACR functional classes I-III, onset must be after age 16 years. 4. RA must have been present for at least 6 months. 5. Taking methotrexate for at least 6 months with a weekly dose between 10-25 mg (or 7.5mg if a higher dose was not tolerated) and the dose must have been stable for the last 8 weeks. 6. At least 4 (out of 28) tender/painful and swollen joints and a CRP= 4 mg/L. 7. Low dose glucocorticoid (=10 mg prednisolone equivalent), NSAIDs, COX-2 inhibitors, codeine are allowed but must have been taken at a stable dose for 4 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding 2. History of other inflammatory joint disease or any arthritis with onset prior to age 16 years 3. Require halofantrine, mefloquine, any known disease modifying therapy (DMARD) 4. QTc >470ms 5. Any of the following conditions: Diabetes mellitus, history/current therapy for lymphoma, leukaemia, malignant melanoma, active infection, known HIV, positive serology for hepatitis B or C, history of cardiac conduction disorders, significant hepatic or renal insufficiency, clinically significant abnormal laboratory parameters (not including CRP), sensitivity to antimalarial or related compounds or active depression or recent history of depression, generalised anxiety disorders or convulsions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the clinical efficacy of three doses of AD 452 in the treatment of subjects with active rheumatoid arthritis who are currently taking methotrexate.;Secondary Objective: Evaluate the safety and tolerability of AD 452 in subjects with active rheumatoid arthritis. An assessment of the impact of steady state plasma exposure on efficacy and safety will be explored. ;Primary end point(s): ACR20 response at week 12 | — |
Countries
Germany, United Kingdom
Outcome results
None listed