Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: AZD9567; Prednisolone
Intervention description: oral OD SGRM administered as suspension; oral capsules of 20 mg prednisolone administered OD for two weeks
Intervention MeSH terms: Prednisolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind, parallell arm study with two weeks treatment of AZD9567 or prednisolone
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double dummy technique
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis, swollen joints, tender joints, autoimmunity

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.
    

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