Arthritis, PsoriaticPhase 3FUTURE 4NCT02294227
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
A Phase 3 study testing Secukinumab in people with Arthritis, Psoriatic, run by Novartis Pharmaceuticals at 64 sites in 13 countries.
Trial summary
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 341 participants
- Where
- 64 sitesin 13 countries
- Study dates
- 29 May 2015to 19 Dec 2017
- 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
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
- Inadequate control of symptoms with NSAID.
- Other protocol-defined inclusion criteria do apply.
Who cannot join
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- Subjects taking high potency opioid analgesics.
- Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- Ongoing use of prohibited psoriasis treatments / medications.
- Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
- Previous treatment with any cell-depleting therapies.
Trial locations and contacts
64 sites in 13 countries.
64 sites in 13 countries
United States19 sites
Novartis Investigative Site
Albany, New York, 12206
Novartis Investigative Site
Burlington, Vermont, 05401
Novartis Investigative Site
Charleston, South Carolina, 29460
Novartis Investigative Site
Denver, Colorado, 80230
Novartis Investigative Site
Duncansville, Pennsylvania, 16635
Novartis Investigative Site
Greenville, South Carolina, 29601
Novartis Investigative Site
Lincoln, Nebraska, 68516
Novartis Investigative Site
Mesa, Arizona, 85202
Novartis Investigative Site
Mesquite, Texas, 75150
Novartis Investigative Site
Oklahoma City, Oklahoma, 73103
Novartis Investigative Site
Palm Harbor, Florida, 34684
Novartis Investigative Site
Peoria, Illinois, 61602
Novartis Investigative Site
Saint Clair Shores, Michigan, 48081
Novartis Investigative Site
Sarasota, Florida, 34239
Novartis Investigative Site
Seattle, Washington, 98104
Novartis Investigative Site
Seattle, Washington, 98122
Novartis Investigative Site
Shreveport, Louisiana, 71101
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
Upland, California, 91786
Germany8 sites
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt am Main, 60528
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hamburg, 20095
Novartis Investigative Site
Hamburg, 22415
Novartis Investigative Site
Herne, 44649
Novartis Investigative Site
Magdeburg, 39110
Novartis Investigative Site
Nienburg, 31582
Poland6 sites
Novartis Investigative Site
Bialystok, 15-461
Novartis Investigative Site
Dopiewo, 62 069
Novartis Investigative Site
Elblag, 82-300
Novartis Investigative Site
Lodz, 90-265
Novartis Investigative Site
Poznan, 60-218
Novartis Investigative Site
Poznan, 61 113
Czechia5 sites
Novartis Investigative Site
Bruntál, Czech Republic, 792 01
Novartis Investigative Site
Hlučín, Czech Republic, 748 01
Novartis Investigative Site
Prague, Czech Republic, 128 50
Novartis Investigative Site
Prague, Czech Republic, 140 00
Novartis Investigative Site
Uherské Hradiště, Czech Republic, 686 01
Russia5 sites
Novartis Investigative Site
Petrozavodsk, 185019
Novartis Investigative Site
Saint Petersburg, 190068
Novartis Investigative Site
Yaroslavl, 150003
Novartis Investigative Site
Yekaterinburg, 620028
Novartis Investigative Site
Yekaterinburg, 620035
Australia4 sites
Novartis Investigative Site
Hobart, Tasmania, 7000
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Malvern East, Victoria, 3145
Novartis Investigative Site
Maroochydore, Queensland, 4558
Belgium4 sites
Novartis Investigative Site
Aalst, 9300
Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Yvoir, 5530
Canada4 sites
Novartis Investigative Site
Pointe-Claire, Quebec, H9R 3J1
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 1Y2
Novartis Investigative Site
Victoria, British Columbia, V8V 3M9
Novartis Investigative Site
Winnipeg, Manitoba, R3A 1M1
Italy3 sites
Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Verona, VR, 37126
Bulgaria2 sites
Novartis Investigative Site
Plovdiv, 4000
Novartis Investigative Site
Sofia, 1431
France2 sites
Novartis Investigative Site
Le Mans, 72037
Novartis Investigative Site
Montpellier, 34195
United Kingdom1 site
Novartis Investigative Site
Leytonstone, London, E11 1NR
About this study
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy
- Conditions
- Arthritis, Psoriatic
- Being tested
- Secukinumab, Placebo
- Keywords
- AIN457, psoriatic arthritis, chronic inflammatory disease, loading regimen, secukinumab, self-injection
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabBiological
Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.
PlaceboOther
Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab 150 mg | Experimental | Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator Receives: Biological: Secukinumab |
| Secukinumab 150 mg No load | Experimental | Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator Receives: Biological: Secukinumab |
| Placebo | Placebo comparator | Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With American College of Rheumatology 20 (ACR20) Response
The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria:
Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
Measured: 16 weeks
Secondary outcomes (5)
Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16
DAS28-CRP score change from baseline using MMRM up to Week 16. DAS-CRP values range between 2.0 and 10. The higher the score, the higher the disease severity.
n: Number of subjects with measures at both baseline and the corresponding post baseline visit.
Measured: week 16
Psoriatic Area and Severity Index 75 (PASI75)
PASI is a measure of disease activity based on extent of the disease, severity of erythema, scaling and thickness in different body areas affected by psoriasis. PASI75 is an improvement in the PASI score of at least 75% compared to baseline. PASI75 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
PASI75 response using non-responder imputation and rescue penalty up to Week 16
Measured: 16 weeks
Short Form Health Survey Physical Component Score (SF-36-PCS)
SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Measured: 16 weeks
Number of Participants With American College of Rheumatology 50 (ACR50)
The ACR50 response is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)].
ACR50 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
This table is the ACR50 response using non-responder imputation and rescue penalty up to Week 16
Measured: 16 weeks
Number of Participants With American College of Rheumatology 20 (ACR20) Response
The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Diability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study start29 May 2015
- Primary completion16 Feb 2016
- Study completion19 Dec 2017
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 (3)Papers the sponsor has linked to this study.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294227
- Sponsor's protocol ID
- CAIN457F2336
- Other IDs
- 2014-003849-10, 2014
- Acronym
- FUTURE 4
- Status last verified
- Jun 2019
- First submitted
- 17 Nov 2014
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
PubMed 38446397Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.
PubMed 34795065Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21.
PubMed 31228101
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)
- ClinicalTrials.gov ID
- NCT02294227
- Acronym / sponsor ID
- FUTURE 4 / CAIN457F2336
- Conditions
- Arthritis, Psoriatic
- Keywords
- AIN457, psoriatic arthritis, chronic inflammatory disease, loading regimen, secukinumab, self-injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2015 (actual)
- Primary completion
- 16 Feb 2016 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Secukinumab 150 mg | Experimental | Biological: SecukinumabSecukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| Secukinumab 150 mg No load | Experimental | Biological: SecukinumabSecukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
| Placebo | Placebo comparator | Other: PlaceboPlacebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
- Inadequate control of symptoms with NSAID.
- Other protocol-defined inclusion criteria do apply.
Key exclusion criteria (6 listed)
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- Subjects taking high potency opioid analgesics.
- Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- Ongoing use of prohibited psoriasis treatments / medications.
- Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
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 |
|---|---|---|
| SecukinumabSecukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg. | Biological | Secukinumab 150 mg, Secukinumab 150 mg No load |
| PlaceboPlacebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug. | Other | Placebo |
Primary outcome
Number of Participants With American College of Rheumatology 20 (ACR20) Response
Time frame: 16 weeks
The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
5 secondary outcomes
Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16
Time frame: week 16
Psoriatic Area and Severity Index 75 (PASI75)
Time frame: 16 weeks
Short Form Health Survey Physical Component Score (SF-36-PCS)
Time frame: 16 weeks
Number of Participants With American College of Rheumatology 50 (ACR50)
Time frame: 16 weeks
Number of Participants With American College of Rheumatology 20 (ACR20) Response
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38446397Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
- Derived from this study: PubMed 34795065Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.
- Derived from this study: PubMed 31228101Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21.
- Introduction to clinical trials conducted by Novartis and to results of completed studies, with the aim of increasing the transparency of Novartis clinical research and making publicly available objective scientific information in a standardised format.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
64 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab in people with Arthritis, Psoriatic, run by Novartis Pharmaceuticals at 64 sites in 13 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Germany, Poland, Czechia, Russia and 8 more countries. 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 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 2 Jul 2019). 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?
Number of Participants With American College of Rheumatology 20 (ACR20) Response (time frame: 16 weeks). 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 NCT02294227, which also lists 3 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 2 Jul 2019.