Phase 2
Completed N=19
Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA
Source: ClinicalTrials.gov NCT04247815 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Mar 2023
Primary outcomePrimary: The Primary Outcome Measure is the Determination of the Safety and Tolerability of ATI-450 Plus Methotrexate in Patients With Moderate to Severe Rheumatoid Arthritis: Adverse Events (AEs) — 8; 2 Participants
Summary
This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure is the Determination of the Safety and Tolerability of ATI-450 Plus Methotrexate in Patients With Moderate to Severe Rheumatoid Arthritis: Adverse Events (AEs) |
8; 2 | — |
| SECONDARY Percent Change in (hsCRP) Levels Over Time |
-75.00; -16.50; -72.40; 15.50; -51.10; -50.20 | — |
| SECONDARY Change From Baseline in Disease Activity Score |
5.72; 6.00; 4.33; 6.15; 4.26; 5.25 | — |
| SECONDARY Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time |
0; 0; 2; 0; 3; 0 | — |
| SECONDARY Change From Baseline in RAMRIS Hand-Wrist Assessments (Osteitis Average) |
0.97; 0.88 | — |
| SECONDARY Change From Baseline in RAMRIS Hand-Wrist Assessments (Synovitis Average) |
0.08; 1.50 | — |
| SECONDARY Number and Percent of Patients Achieving ACR 20 |
8; 0; 8; 0; 9; 0 | — |
| SECONDARY Number and Percent of Patients Achieving ACR 50 |
2; 0; 4; 0; 5; 0 | — |
| SECONDARY Number and Percent of Patients Achieving ACR 70 |
0; 0; 3; 0; 3; 0 | — |
| SECONDARY Assessment of ATI-450 Concentration (ng/mL) |
225.87; 163.97; 131.51; 135.67; 170.84; 153.45 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
- DAS28-CRP ≥3.2 defined as moderate to high disease activity.
- Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints.
- hsCRP ≥5 mg/L at screening.
- Patients must have definitive intra-articular synovitis or osteitis defined as a score of 1 or greater on a Hand-Wrist MRI as assessed by central imaging reader (using RAMRIS).
- On a stable MTX dose and a stable dose of folic or folinic acid prior to the screening visit.
Exclusion Criteria
- Patient has a current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
- Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results.
- History or evidence of active or latent tuberculosis.
- Active infection requiring treatment with antibiotics.
- Blood pressure levels (in supine position after at least 5 minutes rest): 140 mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure.
- Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit.
- Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of the screening visit.
- Patients with history of stroke.
- Any joint procedure in the past 90 days prior to screening.
Data sourced from ClinicalTrials.gov (NCT04247815). 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.