Status:
COMPLETED
Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis
Lead Sponsor:
AstraZeneca
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a phase 2a study to be run in 2-3 countries in European Union involving 5-6 sites. It will enroll approximately 80 patients to ensure 40 randomized with active rheumatoid arthritis. The treatm...
Detailed Description
This randomized double blind with double dummy technique phase 2a study will be run in 2-3 EU countries, most likely Sweden, Denmark and The Netherlands involving 5-6 sites. It is estimated that 80-10...
Eligibility Criteria
Inclusion
- Established RA diagnosis according to the 2010 American College of Rheumatology (ACR)/EULAR classification or the 1987 criteria
- Active RA (DAS28-CRP score ≥ 3.2) with at least 3 swollen joints and 3 tender joints using the DAS28 joint count
- 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
- CRP levels \>5mg/L at screening if seronegative for Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide antibody (anti-CCP Ab), or \>2mg/L if seropositive for either marker
- BMI between 18 and 35 (inclusive)
- Negative pregnancy test (serum) for female subjects of childbearing potential
Exclusion
- History or current inflammatory rheumatic disease other than RA (secondary Sjogren's syndrome excluded)
- 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
- Any clinical contraindications to treatment with steroids
- 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
- Use of any prohibited medication during the study or if the required washout time of such medication was not adhered to
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar class to study drugs
- Any concomitant medications that are known to be associated with Torsades de Pointes
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03368235
Start Date
January 18 2018
End Date
November 12 2019
Last Update
October 5 2020
Active Locations (5)
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1
Research Site
Enschede, Netherlands, 7512 KZ
2
Research Site
Maastricht, Netherlands, 6229 HX
3
Research Site
Utrecht, Netherlands, 3584 CX
4
Research Site
Gothenburg, Sweden, 413 45