Phase 2
Completed N=21
Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT03368235 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Oct 2020
Primary outcomePrimary: Least Square (LS) Mean Change From Baseline in 28 Joint Disease Activity Score Using C-Reactive Protein (DAS28-CRP) at Day 15 — -1.931; -2.403 score on a scale — p=0.315
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Square (LS) Mean Change From Baseline in 28 Joint Disease Activity Score Using C-Reactive Protein (DAS28-CRP) at Day 15 |
-1.931; -2.403 | 0.315 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Responses |
63.6; 70.0; 36.4; 70.0; 18.2; 50.0 | 0.807 |
| SECONDARY LS Mean Change From Baseline in SJC66 Score at Day 15 |
-6.24; -6.66 | 0.717 |
| SECONDARY LS Mean Change From Baseline in TJC68 Score at Day 15 |
-9.02; -7.90 | 0.724 |
| SECONDARY LS Mean Change From Baseline in TJC28 Score at Day 15 |
-6.12; -6.07 | 0.973 |
| SECONDARY LS Mean Change From Baseline in SJC28 Score at Day 15 |
-5.14; -5.40 | 0.757 |
| SECONDARY LS Mean Change From Baseline in GH Score at Day 15 |
-27.7; -37.4 | 0.325 |
| SECONDARY LS Mean Change From Baseline in CRP at Day 15 |
-10.830; -15.586 | 0.187 |
| SECONDARY LS Mean Change From Baseline in Participant's Assessment of Pain Score at Day 15 |
-27.3; -43.4 | 0.144 |
| SECONDARY LS Mean Change From Baseline in Physician's Global Assessment of Disease Activity Score at Day 15 |
-37.0; -40.9 | 0.512 |
| SECONDARY LS Mean Change From Baseline in Participant's Assessment of Physical Function Score at Day 15 |
-0.441; -0.571 | 0.589 |
| SECONDARY Area Under the Plasma Concentration-Time Curve Until the Last Quantifiable Concentration (AUClast) of AZD9567 |
17800 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to 6 Hours After Dose (AUC0-6) of AZD9567 |
17740 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of AZD9567 |
4468 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of AZD9567 |
0.67 | — |
| SECONDARY Last Plasma Concentration Measured Before the Last Dose (Ctrough) of AZD9567 |
NA | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03368235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.