Patients with Rheumatoid Arthritis Level: PT Classification code 10039073
Conditions
Interventions
Product Name: Platelet Rich Plasma
Pharmaceutical Form: Solution for injection
Current Sponsor code: PRPIN AR2006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with RA for longer than 6 months and less than 2 years. 2. Disease in active phase (DAS 28 >5.1, SDAI >24.5) 3. Signs of erosions in at least 1 articular site 4. Positive reactions for anti-CCP's antibodies. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Systemic infections 3 motnhs prior enrollment. 2. HCV and HBV infections. 3. pregnancy. 4.dermtatitis or infections present in studied sites. 5. Neoplasiae. 6. any tipe of infiltration present in studied sites during the last 3 months prior enrollment 7.Bisphosphonate i.v. use or teriparatide. 8. corticosteroid use at doses higher than 7,5 mg Prednisone equivalent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy of platelet gel infilatrations in the reparation of single rheumathoid erosions using NMR observation, power Doppler ecography and traditional Xrays;Secondary Objective: To evaluate the efficacy of autologous platelet gel infiltrations in the reduction of global ersosions in treated patients vs control groups treated only with biological drugs;Primary end point(s): to evaluate the efficacy of platelet gel infilatrations in the reparation of single rheumathoid erosions using NMR observation, power Doppler ecography and traditional Xrays | — |
Countries
Italy
Outcome results
None listed