Rheumatoid Arthritis of KneePhase 4NCT03215407
The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone
A Phase 4 study testing Intra-articular Tocilizumab and Intra-articular Compound Betamethasone in people with Rheumatoid Arthritis of Knee, run by Chinese PLA General Hospital.
Trial summary
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone. Study design: A randomized, single-blind, parallel controlled and one center trial design. Sample size: 60 cases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis of Knee
- What is being tested?
- Intra-articular Tocilizumab and Intra-articular Compound Betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 3 Mar 2018
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-65 years
- Patients must be diagnosed as rheumatoid arthritis according to the 2010 ACR classification diagnostic criteria for RA for at least 6 months.
- Patients' knee is swelling or has effusion.
- Patients have used the same dosage of DMARDs or biologics for at least 6 weeks and continue using the drug until the end of the study.
- If patients are using glucocorticoid or NSAIDs, the dosage must be stabilized for at least 4 weeks and continue until the end of the study.
- Patients must understand the aim and steps of this study, can come back for follow-up timely.
Who cannot join
- Patients' knee is out of shape. X-ray shows a moderate or severe damage of subchondral bone, or joint space is less than 3 mm.
- Patients have received intra-articular injection of glucocorticoid or TNFi, joint replacement, or synovectomy.
- Patients is suffering from other autoimmune diseases or Spondyloarthritis.
- The skin of knee is damaged severely.
- Patients is suffering from pulmonary tuberculosis, or Chest X-ray shows lesion signs related to tuberculosis.
- For the last 3 months, patients have participated in other new drug's clinical trial.
- Other patients who have been thought not suitable for the study by researchers.
About this study
Official title: The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone.
Study design: A randomized, single-blind, parallel controlled and one center trial design.
Read more
Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group. In the baseline period, the investigators will collect patients' general information, disease information, disease activity score, laboratory results and images of articular ultrasound. After 4 weeks of injection, patients will be asked to come back, and their disease information, disease activity score, laboratory results as well as images of articular ultrasound will be collected. Finally, these data will be sorted and analyzed.
Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.
Read the detailed description
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone.
Study design: A randomized, single-blind, parallel controlled and one center trial design, the study period is 4 weeks.
Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group according to the random number table. In the baseline period, the investigators will collect patients' general information, disease information, disease activity score, laboratory results and images of articular ultrasound. After 4 weeks of injection, patients will be asked to come back, and their disease information, disease activity score, laboratory results as well as images of articular ultrasound will be collected. Finally, these data will be sorted and analyzed.
Index of effect evaluation: 1) Articular ultrasound, OMERACT-EULAR composite PDUS synovitis score will be used to evaluate the condition of articulation; 2) Disease activity score, DAS28-CRP, DAS28-ESR; 3) Health Assessment Questionnaire, HAQ; 4) Rheumatoid and arthritis outcome score, RAOS; 5) composite change index, CCI score; 6) diameter of knee joint; 7) knee flexion range.
Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.
- Conditions
- Rheumatoid Arthritis of Knee
- Being tested
- Intra-articular Tocilizumab, Intra-articular Compound Betamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular TocilizumabDrug
Patients will be randomly chosen to be intra-articular injected of tocilizumab injection
Intra-articular Compound BetamethasoneDrug
Patients will be randomly chosen to be intra-articular injected of compound betamethasone injection
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Tocilizumab | Experimental | Tocilizumab, solution, 80mg intra-articular. Receives: Drug: Intra-articular Tocilizumab |
| Intra-articular Compound Betamethasone | Active comparator | Compound betamethasone, solution, 14mg intra-articular Receives: Drug: Intra-articular Compound Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks
use articular ultrasound to explore the condition of knee and evaluate the condition of knee by OMERACT-EULAR composite PDUS synovitis score
Measured: 0 and 4 weeks
Secondary outcomes (6)
change from disease activity score at 4 weeks
DAS28-CRP, DAS28-ESR
Measured: 0 and 4 weeks
change from Health Assessment Questionnaire at 4 weeks
HAQ
Measured: 0 and 4 weeks
change from Rheumatoid and arthritis outcome score at 4 weeks
RAOS
Measured: 0 and 4 weeks
change from composite change index at 4 weeks
CCI score
Measured: 0 and 4 weeks
change from diameter of knee joint at 4 weeks
diameter of knee joint
Measured: 0 and 4 weeks
change from knee flexion range at 4 weeks
knee flexion range
Measured: 0 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion12 Dec 2017 (estimated)
- Study completion3 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis of KneeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215407
- Sponsor's protocol ID
- ChinaPLAGH(Intraarticular+TCZ)
- Status last verified
- Jul 2017
- First submitted
- 22 Jun 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee
- ClinicalTrials.gov ID
- NCT03215407
- Acronym / sponsor ID
- ChinaPLAGH(Intraarticular+TCZ)
- Conditions
- Rheumatoid Arthritis of Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 12 Dec 2017 (estimated)
- Study completion
- 3 Mar 2018 (estimated)
- First posted
- 12 Jul 2017 (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.
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone.
Study design: A randomized, single-blind, parallel controlled and one center trial design.
Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group. In the baseline period, the investigators will collect patients' general information, disease information, disease activity score, laboratory results and images of articular ultrasound. After 4 weeks of injection, patients will be asked to come back, and their disease information, disease activity score, laboratory results as well as images of articular ultrasound will be collected. Finally, these data will be sorted and analyzed.
Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.
Detailed description
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and compound betamethasone.
Study design: A randomized, single-blind, parallel controlled and one center trial design, the study period is 4 weeks.
Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group according to the random number table. In the baseline period, the investigators will collect patients' general information, disease information, disease activity score, laboratory results and images of articular ultrasound. After 4 weeks of injection, patients will be asked to come back, and their disease information, disease activity score, laboratory results as well as images of articular ultrasound will be collected. Finally, these data will be sorted and analyzed.
Index of effect evaluation: 1) Articular ultrasound, OMERACT-EULAR composite PDUS synovitis score will be used to evaluate the condition of articulation; 2) Disease activity score, DAS28-CRP, DAS28-ESR; 3) Health Assessment Questionnaire, HAQ; 4) Rheumatoid and arthritis outcome score, RAOS; 5) composite change index, CCI score; 6) diameter of knee joint; 7) knee flexion range.
Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Tocilizumab | Experimental | Drug: Intra-articular TocilizumabTocilizumab, solution, 80mg intra-articular. |
| Intra-articular Compound Betamethasone | Active comparator | Drug: Intra-articular Compound BetamethasoneCompound betamethasone, solution, 14mg intra-articular |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range: 18-65 years
- Patients must be diagnosed as rheumatoid arthritis according to the 2010 ACR classification diagnostic criteria for RA for at least 6 months.
- Patients' knee is swelling or has effusion.
- Patients have used the same dosage of DMARDs or biologics for at least 6 weeks and continue using the drug until the end of the study.
- If patients are using glucocorticoid or NSAIDs, the dosage must be stabilized for at least 4 weeks and continue until the end of the study.
Key exclusion criteria (7 listed)
- Patients' knee is out of shape. X-ray shows a moderate or severe damage of subchondral bone, or joint space is less than 3 mm.
- Patients have received intra-articular injection of glucocorticoid or TNFi, joint replacement, or synovectomy.
- Patients is suffering from other autoimmune diseases or Spondyloarthritis.
- The skin of knee is damaged severely.
- Patients is suffering from pulmonary tuberculosis, or Chest X-ray shows lesion signs related to tuberculosis.
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 |
|---|---|---|
| Intra-articular TocilizumabPatients will be randomly chosen to be intra-articular injected of tocilizumab injection | Drug | Intra-articular Tocilizumab |
| Intra-articular Compound BetamethasonePatients will be randomly chosen to be intra-articular injected of compound betamethasone injection | Drug | Intra-articular Compound Betamethasone |
Primary outcome
change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks
Time frame: 0 and 4 weeks
use articular ultrasound to explore the condition of knee and evaluate the condition of knee by OMERACT-EULAR composite PDUS synovitis score
6 secondary outcomes
change from disease activity score at 4 weeks
Time frame: 0 and 4 weeks
change from Health Assessment Questionnaire at 4 weeks
Time frame: 0 and 4 weeks
change from Rheumatoid and arthritis outcome score at 4 weeks
Time frame: 0 and 4 weeks
change from composite change index at 4 weeks
Time frame: 0 and 4 weeks
change from diameter of knee joint at 4 weeks
Time frame: 0 and 4 weeks
change from knee flexion range at 4 weeks
Time frame: 0 and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intra-articular Tocilizumab and Intra-articular Compound Betamethasone in people with Rheumatoid Arthritis of Knee, run by Chinese PLA General Hospital.
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 6 inclusion and 7 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 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks (time frame: 0 and 4 weeks). 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 14 Jul 2017.