NCT04264494

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

February 3, 2020

Last Update Submit

February 14, 2020

Conditions

RA - Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Disease Activity Score 28(DAS28)

    At baseline,3 and 6 months post injection.

Study Arms (2)

PRP group

EXPERIMENTAL

Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints

Procedure: PRP intra articular injection

placebo group

PLACEBO COMPARATOR

Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints.

Procedure: NACL intra articular injection

Interventions

PRP intra articular injectionPROCEDURE

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.

Also known as: PRP Injection.
PRP group
NACL intra articular injectionPROCEDURE

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.

Also known as: Placebo injection(NACL)
placebo group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalia Saif

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 11, 2020

Study Start

February 26, 2018

Primary Completion

January 31, 2021

Study Completion

February 26, 2021

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

EG(1)