An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-000838-64-DK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-13
• Study Completion: 2019-11-12
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 21

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.
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified