Evaluating the Role of Intra-articular Injections of Platelet Rich Plasma (PRP) in Patients With Rheumatoid Arthritis.

Evaluating the Role of Intra-articular Injections of Platelet-rich Plasma (PRP) in Patients With Rheumatoid Arthritis and Its Impact on Disease Activity and Quality of Life.

To evaluate the therapeutic effect of 3 local doses of PRP intra-articular injection in patients with RA regarding the improvement of disease activity and quality of life versus placebo.

Study Overview

• Status: Unknown
• Conditions: RA - Rheumatoid Arthritis
• Intervention / Treatment: Procedure: PRP intra articular injection; Procedure: NACL intra articular injection

Detailed Description

100 patients with RA fulfilling the 2010 ACR-EULAR classification criteria for RA were recruited from the outpatient clinic of the Rheumatology and Rehabilitation department. All patients were subjected to clinical and laboratory assessment, visual analog score (VAS) scale and Health Assessment Questionnaire (HAQ). Fifty patients were injected intra-articularly with 3 doses of PRP and 50 patients who serve as a control injected with 3 doses of placebo at 4 weeks intervals for the tender joints and revaluated at 1, 3 months post the last injection regarding the same evaluating tools.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Dalia Saif

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients diagnosed as RA regarding 2010 new criteria of RA, both sex,aged20-60 years old.

Exclusion Criteria:

• Patients with Local abscess,
• systemic illness as (diabetes mellitus, malignancy),
• patients on opioids analgesics.
• pregnancy, blood disorders(coagulopathy, thrombocytopenia),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP group; Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints	Procedure: PRP intra articular injection; Fifty RA patients were injected intra-articularly with 3 doses of PRP at 4 weeks intervals for the joints with only tenderness (arthralgia without swelling or effusion) and revaluated at 3 and 6 months post the last injection regarding the same evaluating tools.; Other Names: PRP Injection.
Placebo Comparator: placebo group; Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints.	Procedure: NACL intra articular injection; and 50 patients who serve as a control and injected intra-articularly with 3 doses of placebo (NaCl saline) at 4 weeks intervals for the joints with only tenderness (arthralgia without swelling or effusion) and revaluated at 3 and 6months post last injection regarding the same evaluating tools.; Other Names: Placebo injection(NACL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale (VAS).	the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)	Change from baseline to 6 months post injection.
Inflammatory mediators.	By means of ELISA (IL 1 beta and TNF alpha	Change from baseline to 6 months post injection.
Health assessment questionnaire disability index. (HAQ-DI)	Is a patient reported outcome which is usually self-administered by the patient and scales range from 0 (no difficulty) to 3 (unable to do)	Change from baseline to 6 months post injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score 28(DAS28)	to asses disease activity by measuring the number of tender and swollen joints,patient global assessment and ESR. values range from 2.0 (remission) to 10.0 (higher disease activity).	At baseline,3 and 6 months post injection.

Collaborators and Investigators

• Sponsor: Dalia Salah Saif

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): February 26, 2021

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 8, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 1475 (CSL Behring)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: To evaluate the therapeutic effect of 3 local doses of PRP intra-articular injection in patients with RA regarding the improvement of disease activity and quality of life versus placebo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No