Rheumatoid ArthritisPhase 3NCT01063062
A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)
A Phase 3 study testing tocilizumab [RoActemra/Actemra] and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 9 sites in Egypt.
Trial summary
This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- tocilizumab [RoActemra/Actemra] and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 9 sitesEgypt
- Study dates
- 28 Feb 2010to 17 Jan 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years of age
- Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a Disease Activity Score (DAS28) > 3.2 at screening)
- Patients with active RA after more than 12 weeks of treatment with DMARDs
- Patients with inadequate response to a stable dose of non-biologic DMARD
Who cannot join
- Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and able to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA are permitted
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Prior history of or current inflammatory joint disease other than RA
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Egypt9 sites
Alexandria University Hospital; Rheumatology
Alexandria
Alexandria University
Alexandria
Banha Educational Hospital; Rheumatology
Banhā
Kasr El Ainy Hospital; Rheumatology
Cairo, 11562
Ain Shams University Hospital; Rheumatology
Cairo
Bab El Sheereya Hospital; Rheumatology
Cairo
El Hussein University Hospital; Rheumatology
Cairo
Kasr El Ainy Hospital
Cairo
Manial Specialized Hospital; Rheumatology
Cairo
About this study
Official title: A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)
This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- tocilizumab [RoActemra/Actemra], Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tocilizumab [RoActemra/Actemra]Drug
8 mg/kg intravenous infusion every 4 weeks.
MethotrexateDrug
methotrexate as per standard of care in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| tocilizumab | Experimental | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. Receives: Drug: tocilizumab [RoActemra/Actemra]; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.
Measured: Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)
Time to DAS28 Low Disease Activity
Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score <3.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.
Measured: 24 Weeks
Secondary outcomes (15)
Percentage of Participants Achieving DAS28 Clinically Significant Improvement
DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24
Time to DAS28 Clinically Significant Improvement
Time to DAS28 Clinically Significant Improvement was the Time in days from the first infusion of study drug to the achievement of a DAS28 score reduction of at least 1.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.
Measured: 24 Weeks
Percentage of Participants Achieving DAS28 Remission
DAS28 Remission was defined as a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
Measured: Weeks 4, 8, 12, 16, 20, 24
Time to DAS28 Remission
Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
Measured: 24 Weeks
Disease Activity Score 28 (DAS28)
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.
Measured: Weeks 4, 8, 12, 16, 20, 24
C-Reactive Protein (CRP)
Blood was collected for C-Reactive Protein (CRP), a test for inflammation, at Weeks 4, 8, 12, 16, 20 and 24 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL).
Measured: Weeks 4, 8, 12, 16, 20, 24
Erythrocyte Sedimentation Rate (ESR)
Blood was collected for Erythrocyte Sedimentation Rate (ESR), a test to assess inflammation, at Weeks 4, 8, 12, 16, 20, 24 and was analyzed at a central laboratory. ESR was measured in millimeters/hour (mm/hr).
Measured: Weeks 4, 8, 12, 16, 20, 24
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Measured: 24 Weeks
Number of Participants With AE and SAE Related Discontinuation
The number of participants who stopped using the study drug because of an AE or a SAE. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Measured: 24 Weeks
Number of Participants With Serious Infections
A serious infection was an infection that qualified as a Serious Adverse Event (SAE). A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Measured: 24 Weeks
Number of Participants With Elevated AST (SGOT) and ALT (SGPT)
Blood was collected for aspartate aminotransferase (serum glutamic oxaloacetic transaminase) [AST/SGOT] and alanine aminotransferase (serum glutamic pyruvic transaminase) [ALT/SGPT], liver function tests, and were analyzed at a central laboratory. The number of participants with High AST (SGOT) or ALT (SGPT) levels at Week 24 is reported.
Measured: Week 24
Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines
Blood samples were collected for Total Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Desirable ( < 200), Borderline High (200- 239) or High (≥ 240). The number of participants categorized Borderline High or High at each time-point is reported.
Measured: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines
Blood samples were collected for High Density Lipoprotein (HDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the HDL Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Low (< 40) or High (≥ 60). The number of participants with category High at each time-point is reported.
Measured: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines
Blood samples were collected for Low Density Lipoprotein (LDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the LDL Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Optimal (< 100), Near Optimal/Above Optimal (100- 129), Borderline High (130- 159), High (160-189) or Very High (≥ 190). The number of participants categorized Borderline High, High or Very High at each time-point is reported.
Measured: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Number of Participants With Elevated Triglyceride According to ATPIII Guidelines
Blood samples were collected for Triglyceride and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Triglyceride level in milligram/deciliter (mg/dL) was categorized as: Normal (< 150), Borderline High (150- 199), High (200- 499) or Very High (≥ 500). The number of participants categorized Borderline High, High or Very High at each time-point is reported.
Measured: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study start28 Feb 2010
- Primary completion17 Jan 2011
- Study completion17 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063062
- Sponsor's protocol ID
- ML22725
- Status last verified
- Jul 2017
- First submitted
- 3 Feb 2010
- Last updated
- 21 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)
- ClinicalTrials.gov ID
- NCT01063062
- Acronym / sponsor ID
- ML22725
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2010 (actual)
- Primary completion
- 17 Jan 2011 (actual)
- Study completion
- 17 Jan 2011 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Posted 4 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tocilizumab | Experimental | Drug: tocilizumab [RoActemra/Actemra], Drug: MethotrexateParticipants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients ≥ 18 years of age
- Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a Disease Activity Score (DAS28) > 3.2 at screening)
- Patients with active RA after more than 12 weeks of treatment with DMARDs
- Patients with inadequate response to a stable dose of non-biologic DMARD
Key exclusion criteria (3 listed)
- Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and able to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA are permitted
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Prior history of or current inflammatory joint disease other than RA
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 |
|---|---|---|
| tocilizumab [RoActemra/Actemra]8 mg/kg intravenous infusion every 4 weeks. | Drug | tocilizumab |
| Methotrexatemethotrexate as per standard of care in clinical practice. | Drug | tocilizumab |
Primary outcome
Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity
Time frame: Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.
Time to DAS28 Low Disease Activity
Time frame: 24 Weeks
Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score <3.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.
15 secondary outcomes
Percentage of Participants Achieving DAS28 Clinically Significant Improvement
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24
Time to DAS28 Clinically Significant Improvement
Time frame: 24 Weeks
Percentage of Participants Achieving DAS28 Remission
Time frame: Weeks 4, 8, 12, 16, 20, 24
Time to DAS28 Remission
Time frame: 24 Weeks
Disease Activity Score 28 (DAS28)
Time frame: Weeks 4, 8, 12, 16, 20, 24
C-Reactive Protein (CRP)
Time frame: Weeks 4, 8, 12, 16, 20, 24
Erythrocyte Sedimentation Rate (ESR)
Time frame: Weeks 4, 8, 12, 16, 20, 24
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 24 Weeks
Number of Participants With AE and SAE Related Discontinuation
Time frame: 24 Weeks
Number of Participants With Serious Infections
Time frame: 24 Weeks
Number of Participants With Elevated AST (SGOT) and ALT (SGPT)
Time frame: Week 24
Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines
Time frame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines
Time frame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines
Time frame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Number of Participants With Elevated Triglyceride According to ATPIII Guidelines
Time frame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for 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
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
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
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.
Clinical Trials study director
Hoffmann-La Roche
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tocilizumab [RoActemra/Actemra] and Methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 9 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity (time frame: Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)). The study lists 2 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 21 Aug 2017.