Arthritis, RheumatoidPhase 4NCT02919761
Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
A Phase 4 study testing Acthar Gel in people with Arthritis, Rheumatoid, run by Mallinckrodt at 59 sites in 5 countries.
Trial summary
This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Acthar Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 59 sitesin 5 countries
- Study dates
- 7 Nov 2016to 13 Feb 2019
- Phase
- Phase 4
- 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
- Male or nonpregnant, nonlactating female subjects
- Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening
- Has active disease defined as a score of >3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment
- Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit
- May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration
Who cannot join
- Has current rheumatoid disease or inflammatory joint disease other than RA
- Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA
- Has taken B-cell mediated therapies in the 6 months prior to screening
- Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar
- Has history of Type 1 or Type 2 diabetes
- Has any clinically significant infection
Trial locations and contacts
59 sites in 5 countries.
59 sites in 5 countries
United States30 sites
Arthritis & Rheumatology of Georgia, PC
Atlanta, Georgia, 30342
Orthopedic Research Institute
Boynton Beach, Florida, 33472
DJL Clinical Research
Charlotte, North Carolina, 28210
Clinical Research of West Florida
Clearwater, Florida, 33765
Columbia Arthritis Center
Columbia, South Carolina, 29204
Northwest Med Care
Cypress, Texas, 77429
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
Gainesville, Florida, 32607
Indago Research and Health Center
Hialeah, Florida, 33012
Homestead Associates in Research
Homestead, Florida, 33032
Rheumatic Disease Clinical Research Center
Houston, Texas, 77004
Accurate Clinical Research
Houston, Texas, 77034
Laila Hassan, MD, PA
Houston, Texas, 77089
Pioneer Research Solutions
Houston, Texas, 77099
West Tennessee Research Institute
Jackson, Tennessee, 38305
June DO, PC
Lansing, Michigan, 48910
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
Ramesh C. Gupta, MD
Memphis, Tennessee, 38119
Southwest Rheumatology Research
Mesquite, Texas, 75150
Pharmax Research Clinic
Miami, Florida, 33126
Suncoast Research Group, LLC
Miami, Florida, 33135
San Marcus Research Clinic
Miami Lakes, Florida, 33015
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, 71203
Suncoast Clinical Research
New Port Richey, Florida, 34652
Omega Research Consultants-DeBary
Orlando, Florida, 32810
Millennium Research
Ormond Beach, Florida, 32174
Sun Research Institute
San Antonio, Texas, 78215
East Bay Rheumatology Medical Group
San Leandro, California, 94578
Arthritis Research and Treatment Center
Stockbridge, Georgia, 30281
Clinical Research of West Florida
Tampa, Florida, 33603
Inland Rheumatology Clinical Trials
Upland, California, 91786
Mexico18 sites
Centro Especializado en Investigación Clínica
Boca del Río, Veracruz, 94290
Consultorio Privado del Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, 62290
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
Phylasis Clinicas Research S de RL de CV
Estado de México, 54769
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, Jalisco, 44650
Centro Peninsular de Investigacion Clinica S.C.P.
Mérida, Yucatán, 97000
Hospital De Jesus
Mexico City, Mexico City, 06090
Consultorio de Reumatología
Mexico City, Mexico City, 07760
Hospital Universitario Dr. José Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
Centro de Estudios Clínicos y Especialidades Médicas
Monterrey, Nuevo León, 64620
SMIQ
Querétaro, 76090
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí
San Luis Potosí City, San Luís Potosí, 78213
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City, 78200
Centro de Investigacion del Noroeste, S.C.
Tijuana, Estado de Baja California, 22010
INBIOMEDYC Toluca
Toluca, 50130
Unidad de Enfermedades Reumaticas y Cronico Degenerativas
Torreón, 27000
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, 45030
Peru6 sites
Clinica Santa Monica
Lima, 15046
Hospital Nacional Cayetano Heredia
Lima, 15102
ABK Reuma S.R.L. - Medicentro Biociencias
Pueblo Libre, 15084
Clinica Vesalio
San Borja, 15036
Hospital de Apoyo Maria Auxiliadora
San Juán de Miraflores, 15801
Clínica Médica Cayetano Heredia
San Martín de Porres, 15102
Argentina4 sites
Aprillus Asistencia e Investigación
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1046AAQ
DIM Clínica Privada
Ramos Mejía, Buenos Aires, 1704
Centro Polivalente de Asistencia e Investigación Clínica CER San Juan
San Juan, J5402DIL
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, T4000BRD
About this study
Official title: A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment
This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease.
Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR.
Read more
Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks.
A single participant might be involved in the trial for as many as 32 weeks.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Acthar Gel, Placebo
- Keywords
- Persistent disease activity
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar GelDrug
Also called Acthar, H.P. Acthar Gel
80 Units Acthar Gel per 1 mL for subcutaneous injection
PlaceboDrug
Also called Matching Placebo
Matching placebo 1 mL for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1: All Enrolled Participants | Experimental | All participants receive Acthar Gel 1 mL twice weekly for 12 weeks Receives: Drug: Acthar Gel |
| Part 2: Acthar Gel | Experimental | Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks Receives: Drug: Acthar Gel |
| Part 2: Placebo | Placebo comparator | Participants receive Placebo 1 mL twice weekly for an additional 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
LDA is defined as DAS28 <3.2.
Measured: Baseline to Week 12
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
Low disease activity is defined as DAS28 <3.2.
Measured: Week 12 to Week 24
Secondary outcomes (12)
Part 1: Swollen Joint Count by Visit
The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)
The DAS28 is a composite score derived from the following assessments:
- Swollen Joint Count
- Tender Joint Count
- Patient's Global Health
- Erythrocyte Sedimentation Rate
Measured: Baseline to Week 12
Part 2: Swollen Joint Count by Visit During Part 2
The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28)
The DAS28 is a composite score derived from the following assessments:
- Swollen Joint Count
- Tender Joint Count
- Patient's Global Health
- Erythrocyte Sedimentation Rate
Measured: Baseline, Week 12 to Week 24
Part 1: Tender Joint Count by Visit
The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)
The DAS28 is a composite score derived from the following assessments:
- Swollen Joint Count
- Tender Joint Count
- Patient's Global Health
- Erythrocyte Sedimentation Rate
Measured: Baseline to Week 12
Part 2: Tender Joint Count by Visit
The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)
The DAS28 is a composite score derived from the following assessments:
- Swollen Joint Count
- Tender Joint Count
- Patient's Global Health
- Erythrocyte Sedimentation Rate
Measured: Baseline, Week 12 to Week 24
Part 1: Patient-Reported General Health by Visit
Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.
A lower score indicates better general health.
Measured: Baseline to Week 12
Part 2: Patient-Reported General Health by Visit
Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.
A lower score indicates better general health.
Measured: Baseline, Week 12 to Week 24
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit
The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.
The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).
The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.
The ESR is a common test for inflammation and used to derive the DAS28.
The DAS28 is a composite score derived from the following assessments:
- Swollen Joint Count
- Tender Joint Count
- Patient's Global Health
- Erythrocyte Sedimentation Rate
Measured: Baseline to Week 12
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit
The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.
The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).
The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.
The ESR is a common test for inflammation and used to derive the DAS28.
The DAS28 is a composite score derived from the following assessments:
- Swollen Joint Count
- Tender Joint Count
- Patient's Global Health
- Erythrocyte Sedimentation Rate
Measured: Baseline, Week 12 to Week 24
Part 1: Patient's Global Assessment of Pain by Visit
Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.
Measured: Baseline to Week 12
Part 2: Patient's Global Assessment of Pain by Visit
Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.
Measured: Baseline, Week 12 to Week 24
Part 1: Physician's Global Assessment of Disease Activities by Visit
The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.
Measured: Baseline to Week 12
Part 2: Physician's Global Assessment of Disease Activities by Visit
The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.
Measured: Week 12 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start7 Nov 2016
- Primary completion17 Oct 2018
- Study completion13 Feb 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: Single Group; Part 2: Parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Mallinckrodt Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919761
- Sponsor's protocol ID
- MNK14294063
- Status last verified
- Mar 2020
- First submitted
- 26 Sep 2016
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fleischmann R, Furst DE. Safety of repository corticotropin injection as an adjunctive therapy for the treatment of rheumatoid arthritis. Expert Opin Drug Saf. 2020 Aug;19(8):935-944. doi: 10.1080/14740338.2020.1779219. Epub 2020 Jun 16.
PubMed 32497440Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial. Rheumatol Ther. 2020 Jun;7(2):327-344. doi: 10.1007/s40744-020-00199-3. Epub 2020 Mar 17.
PubMed 32185745
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment
- ClinicalTrials.gov ID
- NCT02919761
- Acronym / sponsor ID
- MNK14294063
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Persistent disease activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease.
Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR.
Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks.
A single participant might be involved in the trial for as many as 32 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Part 1: Single Group; Part 2: Parallel
| Arm | Type | Receives |
|---|---|---|
| Part 1: All Enrolled Participants | Experimental | Drug: Acthar GelAll participants receive Acthar Gel 1 mL twice weekly for 12 weeks |
| Part 2: Acthar Gel | Experimental | Drug: Acthar GelParticipants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboParticipants receive Placebo 1 mL twice weekly for an additional 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or nonpregnant, nonlactating female subjects
- Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening
- Has active disease defined as a score of >3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment
- Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit
- May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration
Key exclusion criteria (6 listed)
- Has current rheumatoid disease or inflammatory joint disease other than RA
- Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA
- Has taken B-cell mediated therapies in the 6 months prior to screening
- Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar
- Has history of Type 1 or Type 2 diabetes
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 |
|---|---|---|
| Acthar GelAlso: Acthar, H.P. Acthar Gel80 Units Acthar Gel per 1 mL for subcutaneous injection | Drug | Part 1: All Enrolled Participants, Part 2: Acthar Gel |
| PlaceboAlso: Matching PlaceboMatching placebo 1 mL for subcutaneous injection | Drug | Part 2: Placebo |
Primary outcome
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
Time frame: Baseline to Week 12
LDA is defined as DAS28 <3.2.
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
Time frame: Week 12 to Week 24
Low disease activity is defined as DAS28 <3.2.
12 secondary outcomes
Part 1: Swollen Joint Count by Visit
Time frame: Baseline to Week 12
Part 2: Swollen Joint Count by Visit During Part 2
Time frame: Baseline, Week 12 to Week 24
Part 1: Tender Joint Count by Visit
Time frame: Baseline to Week 12
Part 2: Tender Joint Count by Visit
Time frame: Baseline, Week 12 to Week 24
Part 1: Patient-Reported General Health by Visit
Time frame: Baseline to Week 12
Part 2: Patient-Reported General Health by Visit
Time frame: Baseline, Week 12 to Week 24
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit
Time frame: Baseline to Week 12
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit
Time frame: Baseline, Week 12 to Week 24
Part 1: Patient's Global Assessment of Pain by Visit
Time frame: Baseline to Week 12
Part 2: Patient's Global Assessment of Pain by Visit
Time frame: Baseline, Week 12 to Week 24
Part 1: Physician's Global Assessment of Disease Activities by Visit
Time frame: Baseline to Week 12
Part 2: Physician's Global Assessment of Disease Activities by Visit
Time frame: Week 12 to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32497440Fleischmann R, Furst DE. Safety of repository corticotropin injection as an adjunctive therapy for the treatment of rheumatoid arthritis. Expert Opin Drug Saf. 2020 Aug;19(8):935-944. doi: 10.1080/14740338.2020.1779219. Epub 2020 Jun 16.
- Derived from this study: PubMed 32185745Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial. Rheumatol Ther. 2020 Jun;7(2):327-344. doi: 10.1007/s40744-020-00199-3. Epub 2020 Mar 17.
- Individual participant dataSharing planned: No
Related trials for Arthritis, Rheumatoid
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 Team Leader study director
Mallinckrodt Pharmaceutical
59 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acthar Gel in people with Arthritis, Rheumatoid, run by Mallinckrodt at 59 sites in 5 countries.
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 5 inclusion and 6 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Mexico, Peru, Argentina, Puerto Rico. 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.
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?
Yes. Results are posted in the registry (first posted 23 Mar 2020). 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?
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit (time frame: Baseline to Week 12). 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?
On the ClinicalTrials.gov record for NCT02919761, which also lists 2 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 31 Mar 2020.