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Trial record 2 of 36 for:    SAIF

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264494
Recruitment Status : Active, not recruiting
First Posted : February 11, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dalia Salah Saif, Menoufia University

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.

Condition or disease Intervention/treatment Phase
RA - Rheumatoid Arthritis Procedure: PRP intra articular injection Procedure: NACL intra articular injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 26, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Placebo injection(NACL)




Primary Outcome Measures :
  1. visual analogue scale (VAS). [ Time Frame: Change from baseline to 6 months post injection. ]
    the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)

  2. Inflammatory mediators. [ Time Frame: Change from baseline to 6 months post injection. ]
    By means of ELISA (IL 1 beta and TNF alpha

  3. Health assessment questionnaire disability index. (HAQ-DI) [ Time Frame: Change from baseline to 6 months post injection. ]
    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)


Secondary Outcome Measures :
  1. Disease Activity Score 28(DAS28) [ Time Frame: At baseline,3 and 6 months post injection. ]
    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).



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264494


Locations
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Egypt
Dalia Saif
Cairo, Egypt, 11311
Sponsors and Collaborators
Dalia Salah Saif
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Responsible Party: Dalia Salah Saif, principle investigator, Menoufia University
ClinicalTrials.gov Identifier: NCT04264494    
Other Study ID Numbers: 1475
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases