Study on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - ND

• Conditions: Patients with Rheumatoid Arthritis; Level: PTClassification code 10039073

• Registration Number: EUCTR2006-005391-40-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-05
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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