Rheumatoid Arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: AZD9567
Product Code: AZD9567 monohydrate
Pharmaceutical Form: Oral suspension
INN or Proposed INN: N/A
CAS Number: 1893415-64-9
Current Sponsor code: ADZ9567
Concentration unit: mg/ml m
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
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. 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
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 |
|---|---|
| Main Objective: To assess the efficacy of AZD9567, 80 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, by evaluating Change from baseline in 28 joint Disease Activity Score using CRP (DAS 28 - CRP);Secondary Objective: 1. To further assess the efficacy of AZD9567, 80 mg, versus prednisolone 20 mg in patients with active RA in spite of stable treatment with conventional and/or s.c/i.v. biological DMARDs, by evaluating Proportion of subjects reaching ACR (American College of Rheumatology) 20, 50 and 70 responses Change from baseline in Swollen Joint Count 66 (SJC 66) Change from baseline in Tender Joint Count 68 (TJC 68) Change from baseline in individual components of DAS28 and ACR response criteria 2. To evaluate the pharmacokinetic profile of AZD9567 in patients with active RA (E g but not limited to plasma AUC(0-24), AUC(0-last), Cmax and tmax) 3. To assess the safety and tolerability of AZD9567 in patients with active RA (Adverse events, vital signs, ECG and laboratory parameters (hematology, clinical chemistry and urine);Primary end point(s): • Change from baseline in 28 joint Disease Activity Score using CRP (DAS 28 - CRP);Timepoint(s) of evaluation of this end point: Visit 5, end of treatment, to baseline, Visit 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects reaching ACR (American College of Rheumatology) 20, 50 and 70 responses • Change from baseline in Swollen Joint Count 66 (SJC 66) • Change from baseline in Tender Joint Count 68 (TJC 68) • Change from baseline in individual components of DAS28 and ACR response criteria (number of swollen and tender joints, patients assessments of global disease activity, pain, physician´s global assessment of disease activity, and CRP) E g but not limited to plasma AUC(0-24), AUC(0-last), Cmax and tmax of both AZD9567 and prenisolone Adverse events, vital signs, ECG and laboratory parameters (hematology, clinical chemistry and urine);Timepoint(s) of evaluation of this end point: Visit 5, end of treatment, to baseline, Visit 2 | — |
Countries
Denmark, Netherlands, Sweden
Contacts
Public ContactLaurent Valentin Regulatory Lead
AstraZeneca AB
Outcome results
None listed