A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX
- Registration Number
- NCT02270632
- Lead Sponsor
- Philogen S.p.A.
- Brief Summary
A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.
- Detailed Description
The study is designed to formally demonstrate the superiority of F8IL10 vs placebo and to further evaluate safety and efficacy of two different dosages of F8IL10 when administered to patients receiving MTX.
Patients will be enrolled and double-blind, parallel assigned (via automated randomization system) in a 1:1:1 fashion to one of three different arms:
* Arm 1: placebo + MTX
* Arm 2: F8IL10 30 µg/kg + MTX
* Arm 3: F8IL10 160 µg/kg + MTX
F8IL10 or placebo will be subcutaneously injected once a week for 8 weeks. Treatment will terminate at the earliest of the following: completion of the 8 weeks of therapy, withdrawal of informed consent, unacceptable toxicity/intolerability of the study drug or need to increase MTX, oral corticosteroids or NSAIDs dosages above baseline levels or need to introduce a new DMARD or biologic therapy to control rheumatoid arthritis activity. The study will be conducted in a double blind fashion.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Placebo Placebo Arm 3 F8IL10 F8IL10, 160 μg/kg Arm 2 F8IL10 F8IL10, 30 μg/kg Arm 1 MTX Placebo Arm 2 MTX F8IL10, 30 μg/kg Arm 3 MTX F8IL10, 160 μg/kg
- Primary Outcome Measures
Name Time Method Change from baseline in DAS28-CRPscore At week 9 Mean change from baseline in DAS28-CRP between F8IL10 and placebo arms.
- Secondary Outcome Measures
Name Time Method Absolute score and change from baseline in physician's and patient's global assessments of disease activity (100 mm VAS) 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks Patient's and Physician's global assessment of disease activity.
Absolute score and change from baseline in patient assessment of the pain intensity at each visit (100 mm VAS) 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks Patient's assessment of pain.
Inflammatory parameters CRP or ESR and change from baseline 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks Laboratory assessments (CRP, ESR)
Percentage of Participants With Worst On-Study Hematological and Chemistry Abnormalities 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks Clinically Meaningful Changes in Vital Signs and Physical Examinations 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks Changes in absolute counts and relative percentages of main biomarker/cytokines 1) day 14 - 0 (screening); 2) at week 1; 3) at week 5; 4) at week 9 (EoT); 5) from week 12 up to week 32, every 4 weeks Biomarkers :IgA, IgE, Soluble IL-2 receptor, Soluble IL-1 receptor antagonist, MMP3); cytokines: IL-1α, IL-1β, TNFα, IL2, IL6, IL17, IL18, IL22, VEGF
Proportion of patients that experienced significant change from baseline in functional status (SF-36) 1) week 9; 2) from week 12 up to week 32, every 4 weeks Clinical Remission and low-disease activity (DAS28-CRP) 1) week 9; 2) from week 12 up to week 32, every 4 weeks Proportion of patients achieving clinical remission and clinical low- disease activity according to DAS 28-CRP (DAS28 \< 2.6 and 2.6≤ DAS28 \<3.2, respectively) and time to onset of these criteria.
HAQ score and change from baseline in HAQ score 1) week 1; 2) week 9; 3) from week 12 up to week 32, every 4 weeks Number of Participants with Adverse Events Up to 8 months from randomization Safety and tolerability of subcutaneous F8IL10 when administered in combination with MTX.
Absolute count and change from baseline in tender and swollen joint counts 1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks The tender joint count represents the number of joints in which pain is reported at rest with pressure or on movement.
The swollen joint count represents the number of joints in which there is synovial fluid and/or soft tissue swelling.Proportion of patients that experienced significant change from baseline in functional status (HAQ-DI) 1) week 9; 2) from week 12 up to week 32, every 4 weeks Response rate according to ACR and EULAR criteria 1) week 9; 2) from week 12 up to week 32, every 4 weeks Proportion of patients achieving an ACR clinical response (ACR20, 50 and 70) and time to onset of these criteria.
Clinical Remission and low-disease activity (SDAI score) 1) week 9; 2) from week 12 up to week 32, every 4 weeks Proportion of patients achieving clinical remission and clinical low-disease activity according to SDAI score (SDAI ≤ 3.3 and SDAI ≤ 11.0) and time to onset of these criteria
Human anti-fusion protein antibodies (HAFA) levels 1) day 14 - 0 (screening); 2) at week 1; 3) at week 5; 4) at week 9 (EoT); 5) from week 12 up to week 32, every 4 weeks Investigate the potential induction of human anti-fusion protein antibodies (HAFA) through standard laboratory analysis.
Trial Locations
- Locations (8)
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
HFR Fribourg - Hôpital Cantonal
🇨🇭Fribourg, Switzerland
Universitatsklinikum Freiburg
🇩🇪Freiburg, Germany
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Universitatsklinikum Essen
🇩🇪Essen, Germany
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Schön Klinik Hamburg Eilbek
🇩🇪Hamburg, Germany
Ospedale Luigi Sacco, Milano
🇮🇹Milano, Italy