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AzTrials

Rheumatoid ArthritisPhase 3NCT02293902

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

A Phase 3 study testing Sarilumab SAR153191 (REGN88), Methotrexate and Folic acid in people with Rheumatoid Arthritis, run by Sanofi at 96 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Sarilumab SAR153191 (REGN88), Methotrexate and Folic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
243 participants
Where
96 sitesJapan
Study dates
Nov 2014to Oct 2016
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with >=3 months disease duration.
  • Moderately to severely active RA defined as:
  • At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.
  • High sensitivity C-Reactive Protein (hs-CRP) >=6mg/L at screening visit.

Who cannot join

  • Participants <20 or >75 years of age.
  • Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening.
  • Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

Japan96 sites

  • Investigational Site Number 392010

    Asahi-Shi

  • Investigational Site Number 392001

    Asahikawa-Shi

  • Investigational Site Number 392035

    Asahikawa-Shi

  • Investigational Site Number 392070

    Beppu-Shi

  • Investigational Site Number 392036

    Chiba

  • Investigational Site Number 392083

    Chūōku

  • Investigational Site Number 392047

    Fuchu-Shi

  • Investigational Site Number 392004

    Fukui-shi

  • Investigational Site Number 392007

    Fukuoka

  • Investigational Site Number 392038

    Fukuoka

  • Investigational Site Number 392039

    Fukuoka

  • Investigational Site Number 392078

    Fukushima

  • Investigational Site Number 392054

    Funabashi-Shi

  • Investigational Site Number 392015

    Hachioji-Shi

  • Investigational Site Number 392085

    Hannan-Shi

  • Investigational Site Number 392091

    Hiroshima

  • Investigational Site Number 392098

    Hiroshima

  • Investigational Site Number 392009

    Hitachi-Naka

  • Investigational Site Number 392011

    Hitachi-Naka

  • Investigational Site Number 392030

    Ichinomiya-Shi

  • Investigational Site Number 392002

    Iizuka-Shi

  • Investigational Site Number 392019

    Kagoshima

  • Investigational Site Number 392066

    Kamakura-Shi

  • Investigational Site Number 392086

    Kamogawa-Shi

  • Investigational Site Number 392050

    Kato-Shi

  • Investigational Site Number 392037

    Kawachi-Nagano-Shi

  • Investigational Site Number 392093

    Kawagoe-Shi

  • Investigational Site Number 392099

    Kawasaki-Shi

  • Investigational Site Number 392016

    Kirishima-Shi

  • Investigational Site Number 392013

    Kitakyushu-Shi

  • Investigational Site Number 392024

    Kitakyushu-Shi

  • Investigational Site Number 392045

    Kitakyushu-Shi

  • Investigational Site Number 392063

    Kiyose-Shi

  • Investigational Site Number 392051

    Kobe

  • Investigational Site Number 392097

    Kochi

  • Investigational Site Number 392040

    Koushi-Shi

  • Investigational Site Number 392069

    Kumamoto

  • Investigational Site Number 392089

    Kurashiki-Shi

  • Investigational Site Number 392065

    Kushiro

  • Investigational Site Number 392026

    Matsuyama

  • Investigational Site Number 392081

    Matsuyama

  • Investigational Site Number 392094

    Matsuyama

  • Investigational Site Number 392042

    Meguro-Ku

  • Investigational Site Number 392082

    Meguro-Ku

  • Investigational Site Number 392012

    Mito

  • Investigational Site Number 392034

    Miyagi-Gun

  • Investigational Site Number 392053

    Morioka

  • Investigational Site Number 392032

    Nagano

  • Investigational Site Number 392064

    Nagasaki

  • Investigational Site Number 392043

    Nagoya

  • Investigational Site Number 392056

    Nagoya

  • Investigational Site Number 392076

    Nagoya

  • Investigational Site Number 392080

    Nagoya

  • Investigational Site Number 392031

    Nakano

  • Investigational Site Number 392046

    Narashino-Shi

  • Investigational Site Number 392067

    Narashino-Shi

  • Investigational Site Number 392044

    Nishinomiya-Shi

  • Investigational Site Number 392059

    Ōita

  • Investigational Site Number 392062

    Okayama

  • Investigational Site Number 392008

    Omura-Shi

  • Investigational Site Number 392057

    Osaka

  • Investigational Site Number 392060

    Osaka

  • Investigational Site Number 392061

    Osaka

  • Investigational Site Number 392096

    Osaka

  • Investigational Site Number 392027

    Osaki-Shi

  • Investigational Site Number 392049

    Sagamihara-Shi

  • Investigational Site Number 392072

    Saitama-Shi

  • Investigational Site Number 392075

    Sakaishi

  • Investigational Site Number 392014

    Sapporo

  • Investigational Site Number 392068

    Sapporo

  • Investigational Site Number 392073

    Sapporo

  • Investigational Site Number 392006

    Sasebo-Shi

  • Investigational Site Number 392021

    Sendai

  • Investigational Site Number 392022

    Sendai

  • Investigational Site Number 392033

    Sendai

  • Investigational Site Number 392071

    Sendai

  • Investigational Site Number 392100

    Sendai

  • Investigational Site Number 392029

    Shizuoka

  • Investigational Site Number 392025

    Sumida-Ku

  • Investigational Site Number 392092

    Sumida-Ku

  • Investigational Site Number 392023

    Takaoka-Shi

  • Investigational Site Number 392095

    Takarazuka-Shi

  • Investigational Site Number 392020

    Takasaki-Shi

  • Investigational Site Number 392088

    Takatsuki-Shi

  • Investigational Site Number 392018

    Tokorozawa-Shi

  • Investigational Site Number 392003

    Tomakomai-Shi

  • Investigational Site Number 392005

    Tomakomai-Shi

  • Investigational Site Number 392077

    Tonami-Shi

  • Investigational Site Number 392052

    Toshima-Ku

  • Investigational Site Number 392058

    Toyama

  • Investigational Site Number 392055

    Toyonaka-Shi

  • Investigational Site Number 392074

    Urasoe-Shi

  • Investigational Site Number 392079

    Urayasu-Shi

  • Investigational Site Number 392048

    Yokohama

  • Investigational Site Number 392090

    Yokohama

  • Investigational Site Number 392101

    Yokohama

Other trials in Japan

About this study

Official title: A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Primary Objective:

-To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.

Secondary Objective:

-To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.

Read the detailed description

The total duration of study was expected up to 62 weeks (screening period of 4 weeks, treatment period of 52 weeks, and a 6-week post treatment observation).

Being tested
Sarilumab SAR153191 (REGN88), Placebo (for sarilumab), Methotrexate, Folic acid
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sarilumab SAR153191 (REGN88)Drug

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

  • Placebo (for sarilumab)Other

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

  • MethotrexateDrug

    Dispensed according to local practice.

  • Folic acidDrug

    Dispensed according to local practice.

Study groups in NCT02293902
Study groupRoleWhat they receive
Sarilumab 150 mg/150 mgExperimentalSarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either tender joint count [TJC] or swollen joint count [SJC], or with any other clear lack of efficacy based on investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.
Receives: Drug: Sarilumab SAR153191 (REGN88); Drug: Methotrexate; Drug: Folic acid
Sarilumab 200 mg/200 mgExperimentalSarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.
Receives: Drug: Sarilumab SAR153191 (REGN88); Drug: Methotrexate; Drug: Folic acid
Placebo/Sarilumab 150 mgPlacebo comparatorPlacebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.
Receives: Drug: Sarilumab SAR153191 (REGN88); Other: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic acid
Placebo/Sarilumab 200 mgPlacebo comparatorPlacebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits [at least 4 weeks apart] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.
Receives: Drug: Sarilumab SAR153191 (REGN88); Other: Placebo (for sarilumab); Drug: Methotrexate; Drug: Folic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24

    American College of Rheumatology (ACR) response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); Swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments.

    Measured: Week 24

Secondary outcomes (8)

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AEs that developed or worsened or became serious during double-blind on-treatment period, single-blind on-treatment period up to 6-week post-treatment follow-up period (up to Week 58) were considered treatment-emergent.

    Measured: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

  2. Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

    Criteria for potentially clinically significant vital sign abnormalities:

    • Systolic blood pressure supine (SBP[S]): <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg
    • Diastolic blood pressure supine (DBP[S]): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg
    • Orthostatic systolic blood pressure (SBP[O]): <=-20 mmHg
    • Orthostatic diastolic blood pressure (DBP[O]): <=-10 mmHg
    • Heart rate supine (HR[S]): <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm
    • Weight: >=5% DFB; >=5% IFB

    Measured: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

  3. Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

    Criteria for potentially clinically significant ECG abnormalities:

    • PR Interval: >200 millisecond (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%
    • QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%
    • QT Interval: >500 ms
    • QTc Bazett (QTc B): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms
    • QTc Fridericia (QTc F): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms

    Measured: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

  4. Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters

    Criteria for potentially clinically significant abnormalities:

    • Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L
    • Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)
    • Red blood cells (RBC): >=6 Tera/L
    • Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L
    • White blood cells (WBC): <3.0 Giga/L (Non-Black[NB]) or <2.0 Giga/L (Black[B]); >=16.0 Giga/L
    • Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L
    • Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and < lower limit of normal (LLN); >4.0 Giga/L
    • Monocytes: >0.7 Giga/L
    • Basophils: >0.1 Giga/L
    • Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)

    Measured: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

  5. Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters

    Criteria for potentially clinically significant abnormalities:

    • Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L unfasted or >=7 mmol/L fasted
    • Hemoglobin A1c (HbA1c): >8%
    • Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L
    • LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L
    • Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L

    Measured: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

  6. Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes

    Criteria for potentially clinically significant abnormalities:

    • Sodium: <=129 mmol/L; >=160 mmol/L
    • Potassium: <3 mmol/L; >=5.5 mmol/L
    • Chloride: <80 mmol/L; >115 mmol/L

    Measured: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

  7. Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters

    Criteria for potentially clinically significant abnormalities:

    • Creatinine: >=150 micromol/L; >=30% change from baseline; >=100% change from baseline
    • Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to < 60 mL/min; >=60 to <90 mL/min
    • Blood urea nitrogen: >=17 mmol/L
    • Uric acid: <120 micromol/L; >408 micromol/L

    Measured: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

  8. Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters

    Criteria for potentially clinically significant abnormalities:

    • Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN
    • Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN
    • Alkaline phosphatase: >1.5 ULN
    • Total bilirubin (TBILI): >1.5 ULN; >2 ULN
    • Conjugated bilirubin (CBILI): >1.5 ULN; >2 ULN
    • Unconjugated bilirubin: >1.5 ULN; >2 ULN
    • ALT and TBILI: ALT >3 ULN and TBILI >2 ULN
    • CBILI and TBILI: CBILI >35% TBILI and TBILI >1.5 ULN
    • Albumin: <=25 g/L

    Measured: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm : Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

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
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293902
Sponsor's protocol ID
EFC14059
Other IDs
U1111-1155-7401
Status last verified
Jan 2018
First submitted
13 Nov 2014
Last updated
30 Jan 2018
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • Tanaka Y, Takahashi T, Van Hoogstraten H, Praestgaard A, Kato N, Kameda H. Haemoglobin changes and disease activity in Japanese patients with rheumatoid arthritis treated with sarilumab. Clin Exp Rheumatol. 2023 May;41(5):1129-1139. doi: 10.55563/clinexprheumatol/jq9u8f. Epub 2022 Oct 28.

    PubMed 36305354

  • Tanaka Y, Wada K, Takahashi Y, Hagino O, van Hoogstraten H, Graham NMH, Kameda H. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan. Arthritis Res Ther. 2019 Mar 20;21(1):79. doi: 10.1186/s13075-019-1856-4.

    PubMed 30894208

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sarilumab SAR153191 (REGN88), Methotrexate and Folic acid in people with Rheumatoid Arthritis, run by Sanofi at 96 sites in Japan.

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 4 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in Japan. 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 30 Jan 2018). 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 American College of Rheumatology 20 (ACR20) Response at Week 24 (time frame: Week 24). 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 NCT02293902, 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 30 Jan 2018.

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