Rheumatoid Arthritis
Conditions
Interventions
Patients will be block randomized 1:1 to receive either 40 mg AZD9567 or 20 mg
prednisolone. Since this study is double-blind and AZD9567
and prednisolone are different formulations (oral suspension
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Male and female patients aged 18 through 80 years at screening 3. Established RA diagnosis according to the 2010 American College of Rheumatology (ACR)/EULAR classification or the 1987 criteria 4. Active RA (DAS28-CRP score >= 3.2) with at least 3 swollen joints and 3 tender joints using the DAS28 joint count 5. Patients must have be on stable dosing of conventional and/or s.c./i.v biological DMARDs for the last 8 weeks prior to Visit 1 6. CRP levels >5mg/L at screening if seronegative for RF and anti-CCP Ab, or >2mg/L if seropositive for either marker 7. BMI between 18 and 35 (inclusive) 8. Negative pregnancy test (serum) for female subjects of childbearing potential.
Exclusion criteria
Exclusion criteria: 1. History or current inflammatory rheumatic disease other than RA (secondary Sjogren*s syndrome excluded) 2. History or current clinically important disease which may either put the subject at risk because of participation in the study, or influence the results or the subject*s ability to participate in the study 3. Any clinical contraindications to treatment with steroids 4. Oral or parenteral steroids (beyond study medication) 8 weeks prior to study start and during the study. Stable use and dose of topical and inhaled steroids for longer than 4 w prior to randomization is acceptable 5. Use of any prohibited medication during the study or if the required washout time of such medication was not adhered to (for details see Section 7.7.1) 6. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar class to study drugs 7. Any concomitant medications that are known to be associated with Torsades de Pointes, for additional information see Section 7.7.1) 8. Any clinically significant ECG; vital signs or laboratory abnormalities identified at screening or prior to randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of AZD9567, 40 mg, compared to prednisolone 20 mg in patients with active rheumatoid arthritis in spite of stable treatment with conventional and/or s.c/i.v. biological DMARDs will be assessed by the change from baseline in 28 joint Disease Activity Score using CRP (DAS 28-CRP). | — |
Secondary
| Measure | Time frame |
|---|---|
| - To further assess the efficacy of AZD9567, 40 mg, compared to prednisolone 20 mg in patients with active rheumatoid arthritis in spite of stable treatment with conventional and/or s.c/i.v. biological DMARDs - To evaluate the pharmacokinetic profile of AZD9567 in patients with active rheumatoid arthritis in spite of stable treatment with conventional and/or s.c/i.v. biological DMARDs - To assess the safety and tolerability of AZD9567 in patients with active rheumatoid arthritis in spite of stable treatment with conventional and/or s.c/i.v. biological DMARDs - To evaluate the pharmacokinetic profile of prednisolone in patients with active rheumatoid arthritis in spite of stable treatment with conventional and/or s.c/i.v. biological DMARDs - To assess the responses to AZD9567 of relevant biomarkers. Whole blood and serum/plasma will be collected to enable relevant analyses such as, but not limited to, effects on bone, metabolism and HPA axis. Exploratory variables will be reported in a separate biomarker report and will not be included in the clinical study report (CSR), unless something clinically important is observed. - To obtain optional blood samples for future pharmacogenetic (PGx) research aiming to identify/explore pharmacodynamic biomarkers or genetic variations that may affect the efficacy, pharmacodynamics, safety and tolerability profile related to AZD9567 treatment. Data from the PGx research will not be included in the CSR. | — |
Countries
Netherlands
Outcome results
None listed