A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis
ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPhilogen S.p.A.
About this trial
The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis.
Eligibility criteria
Qualifiers
Patients aged ≥18 and ≤80 years.
Diagnosis of RA according to ACR/EULAR classification criteria (2010) with a disease duration exceeding 6 months.
Presence of arthritis flare(s) suitable for IA injection in a knee, ankle, shoulder, wrist or elbow, despite treatment with stable doses (for at least 3 months) of DMARDs (conventional, biologic, and targeted synthetic) background therapy.
No or stable regimens of NSAIDs and/or oral corticosteroid (≤ 10 mg/day; prednisone equivalent) for a period ≥2 weeks prior to screening.
Disqualifiers
Presence of additional RA flares or RA-related symptoms that, in the investigator's judgment, are likely to require local treatment during the study (defined as intra-articular or peri-articular injections/procedures intended to treat RA; e.g., joint, tendon-sheath, or bursal corticosteroid injections; hyaluronic acid; biologic/PRP injections; or radio synovectomy)._
Presence of active infections or another severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or would interfere with the study objectives or conduct.
Pregnancy, lactation or unwillingness to use adequate contraceptive methods.
Diagnosis of any other inflammatory arthritis or active autoimmune diseases other than RA.
Trial design
Treatments tested in this trial
- F8IL10
Treatment groups
42 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov