RA - Rheumatoid ArthritisNCT04264494
Evaluating the Role of Intra-articular Injections of Platelet Rich Plasma (PRP) in Patients With Rheumatoid Arthritis.
A study testing PRP intra articular injection and NACL intra articular injection in people with RA - Rheumatoid Arthritis, run by Dalia Salah Saif at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- RA - Rheumatoid Arthritis
- What is being tested?
- PRP intra articular injection and NACL intra articular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2018to 26 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients diagnosed as RA regarding 2010 new criteria of RA, both sex,aged20-60 years old.
Who cannot join
- Patients with Local abscess,
- systemic illness as (diabetes mellitus, malignancy),
- patients on opioids analgesics.
- pregnancy, blood disorders(coagulopathy, thrombocytopenia),
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- RA - Rheumatoid Arthritis
- Being tested
- PRP intra articular injection, NACL intra articular injection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP intra articular injectionProcedure or surgery
Also called PRP 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.
NACL intra articular injectionProcedure or surgery
Also called Placebo injection(NACL)
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints Receives: Procedure: PRP intra articular injection |
| placebo group | Placebo comparator | Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints. Receives: Procedure: NACL intra articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS).
the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)
Measured: Change from baseline to 6 months post injection.
Inflammatory mediators.
By means of ELISA (IL 1 beta and TNF alpha
Measured: 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)
Measured: Change from baseline to 6 months post injection.
Secondary outcomes (1)
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).
Measured: At baseline,3 and 6 months post injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start26 Feb 2018
- Primary completion31 Jan 2021 (estimated)
- Study completion26 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RA - Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalia Salah Saif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dalia Salah Saif, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264494
- Sponsor's protocol ID
- 1475
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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 at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04264494
- Acronym / sponsor ID
- 1475
- Conditions
- RA - Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dalia Salah SaifUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 26 Feb 2021 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Procedure: PRP intra articular injectionFifty RA patients were injected intra-articularly with 3 doses of PRP in their joints |
| placebo group | Placebo comparator | Procedure: NACL intra articular injectionFifty RA patients were injected intra-articularly with 3 doses of saline in their joints. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients diagnosed as RA regarding 2010 new criteria of RA, both sex,aged20-60 years old.
Key exclusion criteria (4 listed)
- Patients with Local abscess,
- systemic illness as (diabetes mellitus, malignancy),
- patients on opioids analgesics.
- pregnancy, blood disorders(coagulopathy, thrombocytopenia),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP intra articular injectionAlso: PRP 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. | Procedure or surgery | PRP group |
| NACL intra articular injectionAlso: Placebo injection(NACL)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. | Procedure or surgery | placebo group |
Primary outcome
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)
Inflammatory mediators.
Time frame: Change from baseline to 6 months post injection.
By means of ELISA (IL 1 beta and TNF alpha
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)
1 secondary outcome
Disease Activity Score 28(DAS28)
Time frame: At baseline,3 and 6 months post injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: Undecided. 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
Related trials for RA - Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP intra articular injection and NACL intra articular injection in people with RA - Rheumatoid Arthritis, run by Dalia Salah Saif at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS). (time frame: Change from baseline to 6 months post injection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.