Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ATI-450; Placebo oral tablet; Methotrexate
Intervention description: Oral, small molecule MK2 inhibitor; Placebo tablet manufactured to match ATI-450 in appearance; 7.5 mg to 25 mg weekly
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, investigator and patient-blind, sponsor-unblinded, parallel group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Arthritis; Rheumatoid

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.
    

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): <90 mmHg or
             >140 mmHg for systolic blood pressure or <40 mmHg 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.