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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
F8IL10
DrugIntra-articular treatment
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT
Occurrence of dose limiting toxicity (DLT)
Time frame
From Day 1 to Day 28 of the treatment2
MAD, MTD and RD
Definition of maximum administered dose (MAD), maximum tolerated dose (MTD) and recommended dose (RD)
Time frame
From Day 1 to Day 28 of the treatment3
AEs, SAEs and DILI
Adverse events (AEs), serious adverse events (SAEs) and Drug-Induced Liver Injury (DILI), based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE).
Time frame
Through study completation (up to 37 weeks)4
Incidence of injection site reactions
Incidence of injection site reactions and general reactions associated with intraarticular administration
Time frame
Through study completation (up to 37 weeks)Secondary outcomes
1
CCI: Composite change index
The CCI is a semiquantitative scoring system designed to assess target joint synovitis by integrating multiple clinical variables. It incorporates changes in joint pain measured by the Visual Analogue Scale (jVAS), clinical evaluation of joint swelling and tenderness, the patient's assessment of functional disability, and both patient and investigator global assessments of treatment efficacy. The resulting score ranges from 0 (no improvement) to 10 (maximal therapeutic effect).
Time frame
Every 4 weeks, up to week 372
SF-36
Changes in Short Form Health Survey 36. The SF-36 is a validated, patient-reported measure of overall health status, comprising multi-item scales measuring each of the following 8 health concepts: (1) physical functioning, (2) role limitations due to physical health, (3) bodily pain, (4) social functioning, (5) emotional well-being, (6) role limitations due to emotional problems, (7) vitality (energy/fatigue), and (8) general health perceptions. Each healt concept is scored separately, with scores ranging from 0 (worst possible health status) to 100 (best possible health status).
Time frame
Every 4 weeks, up to week 373
Joint inflammation
Changes in target joint inflammation (synovitis) assessed by gray-scale ultrasound (GSUS) and power doppler ultrasound (PDUS). Ultrasound assessment of the treated joint will be performed using gray-scale (to evaluate hypoechoic synovial hypertrophy) and power Doppler (to assess synovial vascularity). Semiquantitative scoring will be applied to each modality separately, as well as in a combined score, ranging from grade 0 (normal) to grade 3 (severe synovitis).
Time frame
Every 4 weeks, up to week 374
SDAI
Changes in Simple Disease Activity Index. The SDAI is a validated tool for assessing rheumatoid arthritis disease activity. It sums the tender and swollen joint counts, patient and physician global assessments of disease activity, and C-reactive protein levels in serum. Scores indicate disease activity: ≤3.3 (remission), \>3.3-11 (low), \>11-26 (moderate), and \>26 (high).
Time frame
Every 4 weeks, up to week 37Sponsors and contacts
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Source ClinicalTrials.gov