Symptomatic Osteoarthritis of the KneeEarly Phase 1NCT02995083
Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial
A Early Phase 1 study testing 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine, Normal Saline 10 ml and Air 10 ml in people with Symptomatic Osteoarthritis of the Knee, run by Rush University Medical Center.
Trial summary
To investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the current standard treatment with corticosteroids and an air injection placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Osteoarthritis of the Knee
- What is being tested?
- 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine, Normal Saline 10 ml and Air 10 ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jan 2018
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be between the ages of 18 and 80
- Informed consent has been obtained from the patient
- The patient must have diagnosed symptomatic osteoarthritis of the tibio-femoral or patello-femoral compartment of the target knee for at least 1 month
- The patient has moderate-to-severe knee pain reflected by an average visual analogue scale (VAS) score of 4 or greater (out of a possible 10) over the previous 7 days.
- Radiographic imaging must show grade II-III osteoarthritis on the Kellgren \& Lawrence Scale.
- Patients may have bilateral osteoarthritis but only patients with unilateral symptoms may be included.
Who cannot join
- Knee instability
- A score less than 4 (out of a possible 10) on their intake VAS
- Major axial deviation (>5º valgus or varus deviation as evidenced on a standard of care x-ray.
- Previous surgery at the target knee < 6 months.
- Symptomatic osteoarthritis of the contralateral knee or any other joint.
- Systemic or intra articular injection to any joint with corticosteroids within 6 months prior to screening
Show all 12Show fewer
- Previous joint injection of any type in the past 6 months
- Systemic conditions that could interfere with outcome such as Rheumatoid arthritis, coagulopathy, and anemia.
- Allergy to any of the injected substances.
- Any patient unable to cease NSAID usage (other than low dose aspirin) due to unrelated condition.
- Cognitive impairment or unable to provide informed consent
- Recent knee trauma with violation of the intra-articular bone.
About this study
Official title: Corticosteriods vs. Saline vs. Air Placebo Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial
To investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the current standard treatment with corticosteroids and an air injection placebo.
Read the detailed description
As non-surgical treatments of OA are essential, multiple trials have been done to compare standard of care IA injection therapies to more novel injection treatments, with many of these trials using saline as the control arm. The purpose of using a control arm is to attempt to eliminate placebo effect and help distinguish the true effectiveness of a therapy. There has been controversy over the clinical effect of saline in treating OA with some arguing that saline may have some clinical benefit. If this is true, it could allow for the true effect of standard of care therapies to appear diminished when compared to saline as a placebo. A recent meta analysis looked at the use of saline as a placebo in 38 randomized control trials to determine if intra-articular saline injections for knee OA had a clinical effect. The study found that IA injections of saline significantly improved short-term knee pain in 32 of the studies which involved 1705 patients, p <0.001, and long-term pain was significantly decreased in 19 of the studies involving 1445 patients, p <0.001. It is essential to empirically determine if saline has a clinical effect due to the role it plays as a placebo in many clinical studies of the management of OA with intra-articular injections.
Objective: To investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the current standard treatment with corticosteroids and an air injection placebo.
Study Design: Prospective, single-blinded, randomized, clinical study. Patients will be randomized into three treatment arms in a 1:1:1 fashion with approximately 50 patients in the saline arm, 50 patients in the corticosteroid arm, and 50 patients in the placebo arm.
Null Hypothesis: Clinical knee outcomes of subjects following one intra-articular knee injection of air will be similar to one intra-articular knee injection of saline or corticosteroid for symptomatic patients diagnosed with knee OA.
Statistical Assumptions: Power Analysis
Investigational Arm: 10 ml Saline (Normal Saline)
Control Arm: 1 ml of 40 mg corticosteroid in 9 ml 1% lidocaine (Depo-medrol, Pfizer, New York, New York), 10 ml air (placebo)
Primary Efficacy Endpoint: The primary efficacy endpoint is the mean change in the WOMAC Index score 12 weeks after first injection with regards to baseline score.
Secondary Efficacy Secondary efficacy endpoints include the change in the full Endpoints: WOMAC Index, KOOS, Lysholm, IKDC, VAS, SF-12 and use of rescue medication (steroid at 12 weeks).
Enrollment: Prospective, randomized, clinical study designed to evaluate 150 subjects. All enrolled subjects will have a pre-procedure visit, one treatment visit, and follow-up visits at week 6 and week 12 if they require a rescue injection and will fill out patient reported outcome measures at 1, 6, 12, and 24 weeks.
- Conditions
- Symptomatic Osteoarthritis of the Knee
- Being tested
- 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine, Normal Saline 10 ml, Air 10 ml
- Keywords
- osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaineDrug
Also called Corticosteroid
Patients will receive an ultrasound guided intra-articular injection of 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine
Normal Saline 10 mlDrug
Also called Saline
Patients will receive an ultrasound guided intra-articular injection of Normal Saline 10 ml
Air 10 mlDrug
Also called Air
Patients will receive an ultrasound guided intra-articular injection of Air 10 ml
| Study group | Role | What they receive |
|---|---|---|
| Knee injection with corticosteroids | Active comparator | Using clinically accepted methods, subjects will undergo a palpation guided injection of corticosteroids into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks. Receives: Drug: 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine |
| Knee injection with saline | Placebo comparator | Using clinically accepted methods, subjects will undergo a palpation guided injection of saline into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks. Receives: Drug: Normal Saline 10 ml |
| Knee injection with air | Sham comparator | Using clinically accepted methods, subjects will undergo a palpation guided injection of air into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks. Receives: Drug: Air 10 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Western Ontario and McMaster Universities Arthritis Index score (WOMAC)
Mean change in the WOMAC Index score from baseline score
Measured: 12 weeks after injection
Secondary outcomes (6)
Mean change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Mean change in the KOOS from baseline score
Measured: 12 weeks after injection
Mean change in International Knee Documentation Committee (IKDC) score
Mean change in IKDC from baseline score
Measured: 12 weeks after injection
Mean change in Visual Analogue Scale (VAS)
Mean change in VAS from baseline score
Measured: 12 weeks after injection
Mean change in Short Form 12 (SF-12) score
Mean change in SF-12 from baseline score
Measured: 12 weeks after injection
Mean change in The Lysholm Knee score
Mean change in The Lysholm Knee score from baseline score
Measured: 12 weeks after injection
Mean change in use of rescue medication
Use of anti-inflammatory, analgesics, and rescue corticosteroid injection. Number of pills taken each day. This will be collected via survey. If the medical examiner feels that the patient is continuing to do poorly and they did not receive the steroid injection intervention, then they will be offered a rescue corticosteroid injection at 12 weeks. The number of patients who do not initially receive a corticosteroid injection and require a rescue corticosteroid injection at 12 weeks will be recorded.
Measured: 12 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJun 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Study deemed not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukesh Ahuja, Rush University Medical Center
- Investigators
- Nikhil N Verma, MD, Principal investigator, Midwest Orthopaedics at Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995083
- Sponsor's protocol ID
- 16090902
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2016
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.
PubMed 18759314Altman RD, Devji T, Bhandari M, Fierlinger A, Niazi F, Christensen R. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. Semin Arthritis Rheum. 2016 Oct;46(2):151-159. doi: 10.1016/j.semarthrit.2016.04.003. Epub 2016 Apr 27.
PubMed 27238876Williams VJ, Piva SR, Irrgang JJ, Crossley C, Fitzgerald GK. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation. J Orthop Sports Phys Ther. 2012 Aug;42(8):716-23. doi: 10.2519/jospt.2012.4038. Epub 2012 Mar 8.
PubMed 22402677Kim J, Seo BS. How to calculate sample size and why. Clin Orthop Surg. 2013 Sep;5(3):235-42. doi: 10.4055/cios.2013.5.3.235. Epub 2013 Aug 20.
PubMed 24009911Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008 Dec;67(12):1716-23. doi: 10.1136/ard.2008.092015. Epub 2008 Jun 9.
PubMed 18541604Eker HE, Cok OY, Aribogan A, Arslan G. The efficacy of intra-articular lidocaine administration in chronic knee pain due to osteoarthritis: A randomized, double-blind, controlled study. Anaesth Crit Care Pain Med. 2017 Apr;36(2):109-114. doi: 10.1016/j.accpm.2016.05.003. Epub 2016 Jul 30.
PubMed 27485803
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteriods vs. Saline vs. Air Placebo Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02995083
- Acronym / sponsor ID
- 16090902
- Conditions
- Symptomatic Osteoarthritis of the Knee
- Keywords
- osteoarthritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study deemed not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- 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 investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the current standard treatment with corticosteroids and an air injection placebo.
Detailed description
As non-surgical treatments of OA are essential, multiple trials have been done to compare standard of care IA injection therapies to more novel injection treatments, with many of these trials using saline as the control arm. The purpose of using a control arm is to attempt to eliminate placebo effect and help distinguish the true effectiveness of a therapy. There has been controversy over the clinical effect of saline in treating OA with some arguing that saline may have some clinical benefit. If this is true, it could allow for the true effect of standard of care therapies to appear diminished when compared to saline as a placebo. A recent meta analysis looked at the use of saline as a placebo in 38 randomized control trials to determine if intra-articular saline injections for knee OA had a clinical effect. The study found that IA injections of saline significantly improved short-term knee pain in 32 of the studies which involved 1705 patients, p <0.001, and long-term pain was significantly decreased in 19 of the studies involving 1445 patients, p <0.001. It is essential to empirically determine if saline has a clinical effect due to the role it plays as a placebo in many clinical studies of the management of OA with intra-articular injections.
Objective: To investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the current standard treatment with corticosteroids and an air injection placebo.
Study Design: Prospective, single-blinded, randomized, clinical study. Patients will be randomized into three treatment arms in a 1:1:1 fashion with approximately 50 patients in the saline arm, 50 patients in the corticosteroid arm, and 50 patients in the placebo arm.
Null Hypothesis: Clinical knee outcomes of subjects following one intra-articular knee injection of air will be similar to one intra-articular knee injection of saline or corticosteroid for symptomatic patients diagnosed with knee OA.
Statistical Assumptions: Power Analysis
Investigational Arm: 10 ml Saline (Normal Saline)
Control Arm: 1 ml of 40 mg corticosteroid in 9 ml 1% lidocaine (Depo-medrol, Pfizer, New York, New York), 10 ml air (placebo)
Primary Efficacy Endpoint: The primary efficacy endpoint is the mean change in the WOMAC Index score 12 weeks after first injection with regards to baseline score.
Secondary Efficacy Secondary efficacy endpoints include the change in the full Endpoints: WOMAC Index, KOOS, Lysholm, IKDC, VAS, SF-12 and use of rescue medication (steroid at 12 weeks).
Enrollment: Prospective, randomized, clinical study designed to evaluate 150 subjects. All enrolled subjects will have a pre-procedure visit, one treatment visit, and follow-up visits at week 6 and week 12 if they require a rescue injection and will fill out patient reported outcome measures at 1, 6, 12, and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Knee injection with corticosteroids | Active comparator | Drug: 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaineUsing clinically accepted methods, subjects will undergo a palpation guided injection of corticosteroids into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks. |
| Knee injection with saline | Placebo comparator | Drug: Normal Saline 10 mlUsing clinically accepted methods, subjects will undergo a palpation guided injection of saline into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks. |
| Knee injection with air | Sham comparator | Drug: Air 10 mlUsing clinically accepted methods, subjects will undergo a palpation guided injection of air into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must be between the ages of 18 and 80
- Informed consent has been obtained from the patient
- The patient must have diagnosed symptomatic osteoarthritis of the tibio-femoral or patello-femoral compartment of the target knee for at least 1 month
- The patient has moderate-to-severe knee pain reflected by an average visual analogue scale (VAS) score of 4 or greater (out of a possible 10) over the previous 7 days.
- Radiographic imaging must show grade II-III osteoarthritis on the Kellgren \& Lawrence Scale.
Key exclusion criteria (12 listed)
- Knee instability
- A score less than 4 (out of a possible 10) on their intake VAS
- Major axial deviation (>5º valgus or varus deviation as evidenced on a standard of care x-ray.
- Previous surgery at the target knee < 6 months.
- Symptomatic osteoarthritis of the contralateral knee or any other joint.
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 |
|---|---|---|
| 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaineAlso: CorticosteroidPatients will receive an ultrasound guided intra-articular injection of 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine | Drug | Knee injection with corticosteroids |
| Normal Saline 10 mlAlso: SalinePatients will receive an ultrasound guided intra-articular injection of Normal Saline 10 ml | Drug | Knee injection with saline |
| Air 10 mlAlso: AirPatients will receive an ultrasound guided intra-articular injection of Air 10 ml | Drug | Knee injection with air |
Primary outcome
Mean change in Western Ontario and McMaster Universities Arthritis Index score (WOMAC)
Time frame: 12 weeks after injection
Mean change in the WOMAC Index score from baseline score
6 secondary outcomes
Mean change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 weeks after injection
Mean change in International Knee Documentation Committee (IKDC) score
Time frame: 12 weeks after injection
Mean change in Visual Analogue Scale (VAS)
Time frame: 12 weeks after injection
Mean change in Short Form 12 (SF-12) score
Time frame: 12 weeks after injection
Mean change in The Lysholm Knee score
Time frame: 12 weeks after injection
Mean change in use of rescue medication
Time frame: 12 weeks after injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Background: PubMed 18759314Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.
- Background: PubMed 27238876Altman RD, Devji T, Bhandari M, Fierlinger A, Niazi F, Christensen R. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. Semin Arthritis Rheum. 2016 Oct;46(2):151-159. doi: 10.1016/j.semarthrit.2016.04.003. Epub 2016 Apr 27.
- Background: PubMed 22402677Williams VJ, Piva SR, Irrgang JJ, Crossley C, Fitzgerald GK. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation. J Orthop Sports Phys Ther. 2012 Aug;42(8):716-23. doi: 10.2519/jospt.2012.4038. Epub 2012 Mar 8.
- Background: PubMed 24009911Kim J, Seo BS. How to calculate sample size and why. Clin Orthop Surg. 2013 Sep;5(3):235-42. doi: 10.4055/cios.2013.5.3.235. Epub 2013 Aug 20.
- Background: PubMed 18541604Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008 Dec;67(12):1716-23. doi: 10.1136/ard.2008.092015. Epub 2008 Jun 9.
- Background: PubMed 27485803Eker HE, Cok OY, Aribogan A, Arslan G. The efficacy of intra-articular lidocaine administration in chronic knee pain due to osteoarthritis: A randomized, double-blind, controlled study. Anaesth Crit Care Pain Med. 2017 Apr;36(2):109-114. doi: 10.1016/j.accpm.2016.05.003. Epub 2016 Jul 30.
- Individual participant dataSharing planned: No
Related trials for Symptomatic Osteoarthritis of the Knee
Recruiting
Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis
Cryoneurolysis, Bipolar Radiofrequency Ablation
RecruitingObservational study
Prospective Observational Study Of Geniculate Artery Embolization For Symptomatic Knee Osteoarthritis In A Cancer Population
Observational Study, Geniculate Artery
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.
Nikhil N Verma, MD principal investigator
Midwest Orthopaedics at Rush University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine, Normal Saline 10 ml and Air 10 ml in people with Symptomatic Osteoarthritis of the Knee, run by Rush University Medical Center.
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 12 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: withdrawn, as of the sponsor's last update on 18 Dec 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. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean change in Western Ontario and McMaster Universities Arthritis Index score (WOMAC) (time frame: 12 weeks after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995083, which also lists 6 linked publications.
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 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.