Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis

NCT ID: NCT03368235

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-18
• Study Completion Date: 2019-11-12

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 treatment period is 2 weeks and total study duration per patient is approximately 1 month. The study drugs are AZD9567 40 mg (an oral SGRM) and the comparator is prednisolone 20mg. The primary endpoint is DAS28 including evaluation of 28 joints and C-reactive protein. Safety parameters will also be evaluated and a biomarker program is included for future research.

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 80-100 patients have to be enrolled to ensure the randomization target of 40. The study population is patients with rheumatoid arthritis on stable treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs) with an active flare. It is a two-arm parallel study and the randomization ratio is 1:1 to the two weeks of once daily treatment of 40 mg of AZD9567 and 20 mg prednisolone.

The primary objective is to 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 and the primary variable is change from baseline in 28 joint Disease Activity Score using CRP (DAS28 - CRP). As secondary variables swollen and tenderness of 66-68 joints and safety variables are also included. For exploratively purposes there is also a biomarker program, collecting blood samples for future research.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AZD9567

oral suspension of 40 mg AZD9567 once daily (OD) for two weeks

Group Type: EXPERIMENTAL

AZD9567

Intervention Type: DRUG

oral OD SGRM administered as suspension

Prednisolone

oral OD treatment of 20 mg prednisolone administered as capsules

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

oral capsules of 20 mg prednisolone administered OD for two weeks

Interventions

AZD9567

oral OD SGRM administered as suspension

Intervention Type: DRUG

Prednisolone

oral capsules of 20 mg prednisolone administered OD for two weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Established RA diagnosis according to the 2010 American College of Rheumatology (ACR)/EULAR classification or the 1987 criteria

2. Active RA (DAS28-CRP score ≥ 3.2) with at least 3 swollen joints and 3 tender joints using the DAS28 joint count

3. 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

4. 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

5. BMI between 18 and 35 (inclusive)

6. Negative pregnancy test (serum) for female subjects of childbearing potential

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob M Van Laar, Professor

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

Research Site

Enschede, , Netherlands

Research Site

Maastricht, , Netherlands

Research Site

Utrecht, , Netherlands

Research Site

Gothenburg, , Sweden

Research Site

Lund, , Sweden

Countries

Netherlands; Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Redacted Protocol

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6470C00003&attachmentIdentifier=271824b2-bcd4-4988-ae51-dbad237ee5d5&fileName=D6470C00003_Statistical_Analysis_Plan_28-11-2019.pdf&versionIdentifier=

SAP

Other Identifiers

D6470C00003

Identifier Type: -

Identifier Source: org_study_id