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Rheumatoid ArthritisPhase 3CREDO 1NCT02760368

Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

A Phase 3 study testing Olokizumab in people with Rheumatoid Arthritis, run by R-Pharm International, LLC at 40 sites in 3 countries.

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

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with methotrexate (MTX). 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?
Olokizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
428 participants
Where
40 sitesin 3 countries
Study dates
19 May 2016to Oct 2018
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

  • Subjects may be enrolled in the study only if they meet all of the following criteria:
  • Subjects willing and able to sign informed consent
  • Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 12 weeks prior to Screening.
  • Inadequate response to treatment with MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if intolerant to higher doses).
  • The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening.
  • Subjects must be willing to take folic acid or equivalent throughout the study
Show all 10Show fewer
  • Subjects must have moderately to severely active RA disease as defined by all of the following:
  • ≥6 tender joints (68 joint count) at Screening and baseline; and
  • ≥6 swollen joints (66 joint count) at Screening and baseline; and
  • CRP above ULN at Screening based on the central laboratory results.

Who cannot join

  • Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus). However, subjects could have secondary Sjogren's syndrome or hypothyroidism
  • Subjects who were Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)
  • Prior exposure to any licensed or investigational compound directly or indirectly targeting IL-6 or IL-6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase [SYK] inhibitors)
  • Prior treatment with cell-depleting therapies, including anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, and anti-CD19)
  • Prior use of bDMARDs, with the following exception:
  • Subjects who discontinued TNFi therapy due to a reason other than lack of efficacy were allowed to enter the study (TNFi therapy was not to be discontinued to facilitate a subject's participation in the study but should instead have been previously discontinued as part of a subject's medical management of RA). The use of TNFi therapy within the following windows prior to baseline was exclusionary:
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  • 4 weeks for etanercept
  • 8 weeks for infliximab
  • 10 weeks for adalimumab, certolizumab, and golimumab
  • Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline
  • Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent), or change in dosage within 2 weeks prior to baseline
  • Prior documented history of no response to hydroxychloroquine and sulfasalazine
  • Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs were not to be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):
  • 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline
  • 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours
  • 24 weeks for cyclophosphamide
  • Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study
  • Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline
  • Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline
  • Use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline
  • Previous participation in this study (randomized) or another study of OKZ
  • Subjects with acute or chronic viral hepatitis B or C infection as detected by blood tests at Screening (e.g., positive for hepatitis B surface antigen [HBsAg], total hepatitis B core antibody [anti-HBc], or hepatitis C virus antibody [HCV Ab])
  • Subjects who were positive for hepatitis B surface antibody (anti-HBs), but negative for HBsAg and anti-HBc, were eligible
  • Subjects with HIV infection
  • Subjects with:
  • Suspected or confirmed current active TB disease or a history of active TB disease
  • Close contact (i.e., sharing the same household or other enclosed environment, such as a social gathering place, workplace, or facility, for extended periods during the day) with an individual with active TB within 1.5 years prior to Screening.
  • Concurrent malignancy or a history of malignancy within the last 5 years (with the exception of successfully treated carcinoma in situ of the cervix and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to Screening [and no more than 3 excised skin cancers within the last 5 years prior to Screening])
  • Subjects with any infection requiring oral antibiotic or antiviral therapy in the 2 weeks prior to Screening or at baseline, injectable anti-infective therapy in the last 4 weeks prior to baseline, or serious or recurrent infection with a history of hospitalization in the 6 months prior to baseline
  • Subjects with evidence of disseminated herpes zoster infection, zoster encephalitis, meningitis, or other non-self-limited herpes zoster infections in the 6 months prior to baseline
  • Subjects with planned surgery during the study or surgery ≤4 weeks prior to Screening and from which the subject had not fully recovered, as judged by the Investigator
  • Subjects with diverticulitis or other symptomatic GI conditions that might predispose the subject to perforations, including subjects with a history of such predisposing conditions (e.g., diverticulitis, GI perforation, or ulcerative colitis)
  • Pre-existing central nervous system demyelinating disorders (e.g., multiple sclerosis and optic neuritis)
  • History of chronic alcohol or drug abuse as judged by the Investigator
  • Female subjects who are pregnant, currently lactating, have lactated within the last 12 weeks, or who were planning to become pregnant during the study or within 6 months of last dose of study treatment
  • Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman had experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status [e.g., correlative age] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who were not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment;
  • Subjects with a known hypersensitivity to any component of the OKZ drug product, or placebo
  • Subjects with a known hypersensitivity or contraindication to any component of the rescue medication
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • 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

40 sites in 3 countries.

40 sites in 3 countries

Russia34 sites

  • Regional State Budgetary Healthcare Institution "Barnaul City Hospital #4"

    Barnaul, Altayskiy Kray, 656050

  • State Autonomous Healthcare Institution "Republican Clinical Hospital of Ministry of Health of Tatarstan Republic

    Kazan', The Republic of Tatarstan, 420064

  • SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"

    Kemerovo, Kemerovo Oblast, 650000

  • Medical Center LLC "Maksimum Zdoroviya"

    Kemerovo, Kemerovo Oblast, 650066

  • Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region

    Kursk, Kursk Oblast, 305007

  • FSBEI HE "First Moscow State Medical University n.a. I.M. Sechenov of MoH of Russian Federation", UCH #1

    Moscow, Moscovskaya Oblast, 119435

  • FSBEI HE "FMSMU n.a. I.M. Sechenov of MoH of RF", University Hospital #2, Departament of New Drugs Introduction

    Moscow, Moscovskaya Oblast, 119435

  • SBEI HPE "First Moscow State Medical University n.a. I.M. Sechenov of MoH of Russian Federation" UCH #3

    Moscow, Moscovskaya Oblast, 119435

  • State Budgetary Healthcare Institution of Moscow "City Clinical Hospital #1 n.a. Pirogov" Healthcare Departament of Moscow

    Moscow, Moscovskaya Oblast, 19049

  • State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department

    Moscow, Moscow Oblast, 111539

  • SBHI of Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament"

    Moscow, Moscow Oblast, 115093

  • FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"

    Moscow, 115522

  • SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126

  • City Clinical Hospital №5 of Nizhny Novgorod

    Nizhny Novgorod, 603005

  • State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1"

    Novosibirsk, Novosibirsk Oblast, 630099

  • LLC "Clinical Diagnostic Center "Ultramed"

    Omsk, Omsk Oblast, 644024

  • Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"

    Omsk, Omsk Oblast, 644111

  • SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"

    Petrozavodsk, Republic of Karelia, 185019

  • SBEI HPE "Rostov State Medical University" of Ministry of Health of the Russian Federation

    Rostov-on-Don, Rostov Oblast, 344022

  • Ryazan State Medical University n.a. I.P. Pavlov based on Regional Clinical Cardiology Dispensary

    Ryazan, 390026

  • SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit

    Saint Petersburg, Leningradskaya Oblast', 190068

  • SBHI "North-West Federat Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation

    Saint Petersburg, 197341

  • State Healthcare Institution "Regional Clinical Hospital"

    Saratov, Saratov Oblast, 410053

  • SBEI HPE "SSMU n.a. V.I. Razumovsky of MoH of RF", Clinical Hospital n.a. S.R. Mirotvorcev, Therapeutic Departament

    Saratov, Saratov Oblast, 410054

  • Non-governmental Healtheare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways"

    Smolensk, Smolensk Oblast, 214025

  • SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"

    Stavropol, Stavropol Kray, 355030

  • State Healthcare Institution of Tula region "Tula Regional Clinical Hospital"

    Tula, Tulskaya Oblast, 300053

  • State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov"

    Ufa, Respublic of Bashkortostan, 450005

  • State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"

    Ulyanovsk, Ulyanovsk Oblast, 432063

  • SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament

    Vladimir, Vladimirskaya Oblast’, 600023

  • SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department

    Yaroslavl, Yaroslavl Oblast, 150062

  • State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev"

    Yaroslavl, Yaroslavsakaya Oblast, 150003

  • State Budgetary Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital #1"

    Yekaterinburg, Sverdlovsk Oblast, 620102

  • SBEI HPE "Ural State Medical University" of MoH of RF based MBI "Central City Clinical Hospital #6"

    Yekaterinburg, Sverdlovsk Oblast, 620149

Other trials in Russia

Bulgaria4 sites

  • DCC 'Sv. Pantaleymon' OOD

    Pleven, 5800

  • UMHAT "Kaspela", EOOD

    Plovdiv, 4002

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • MC "Synexus - Sofia", EOOD

    Sofia, 1784

Other trials in Bulgaria

Belarus2 sites

  • City Clinical Hospital #1

    Minsk, 220013

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with methotrexate (MTX).

The primary objective of this study was to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active rheumatoid arthritis (RA) inadequately controlled by methotrexate (MTX) therapy.

Read the detailed description

The goal of this Phase III study was to assess the efficacy, tolerability, and safety of OKZ in subjects with moderately to severely active RA who had responded inadequately to MTX. The primary endpoint of the trial was at Week 12. Olokizumab was expected to reduce the disease activity and improve physical function. The study was expected to provide safety information in a large group of subjects over at least a 24 week period.

The CREDO 1 study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety Follow-Up Period from Week 24 to Week 44.

At randomization, a total of 428 eligible subjects were randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio:

  1. OKZ 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo OKZ q4w to maintain blinding) + MTX.
  2. OKZ 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX.
  3. Placebo: SC injection of placebo q2w + MTX

Throughout the double-blind Treatment Period, all subjects were required to remain on a stable dose of background MTX at 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses) with a stable route of administration, and concomitant treatment with folic acid ≥5 mg per week or equivalent is required for all subjects. The last dose of study treatment (OKZ or placebo) was at Week 22 in all groups.

Following Visit 2 (randomization), subjects returned to the study site at least every other week through Week 24 for response and safety assessments as per the study Schedule of Events.

Subjects were classified in terms of their response to study treatment at Week 14, with non-responders defined as subjects in any treatment group who had not improved by at least 20% in both swollen and tender joint counts (66-68 joint assessment). Starting at or as close as possible to Week 14, non-responders were administered sulfasalazine and/or hydroxychloroquine as rescue medication in addition to the assigned treatment.

After completion of the 24-week double-blind Treatment Period, subjects either rolled over into the long-term open-label extension (OLE) study or entered the Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for visits +4, +8, and +22 weeks after the last dose of study treatment.

Subjects who discontinued the randomized treatment prematurely were required to come for the End of Treatment (EoT) Visit 2 weeks after the last study treatment administration and then continued with the scheduled study visits as per the Schedule of Events.

The study was conducted at approximately 50 sites across 4 countries globally, which included Russia, Belarus, Turkey, and Bulgaria.

Being tested
Olokizumab, Placebo
Keywords
moderate Rheumatoid Arthritis, severe Rheumatoid Arthritis, subcutaneous, Olokizumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • OlokizumabDrug

    160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial

  • PlaceboDrug

    sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules

Study groups in NCT02760368
Study groupRoleWhat they receive
Arm 1: Olokizumab q4wExperimentalOlokizumab 64 mg Subcutaneous q4w +placebo+ Methotrexate (oral) in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)
Receives: Drug: Olokizumab; Drug: Placebo
Arm 2: Olokizumab q2wExperimentalOlokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)
Receives: Drug: Olokizumab
Arm 3: PlaceboPlacebo comparatorPlacebo Subcutaneous q2w + Methotrexate (oral)
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response

    A responder was defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12.

    The calculations were based on a ≥ 20% improvement from baseline in the swollen joint count (SJC) assessed in 66 joints and in the tender joint count (TJC) assessed in 68 joints; and a ≥ 20% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (Visual Analog Scale (VAS) assessment), Patient Assessment of Pain (VAS assessment), Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician Global Assessment (VAS assessment), Level of acute phase reactant (CRP or ESR, using level of CRP in this study).

    Measured: at Week 12

Secondary outcomes (4)

  1. Percentage of Subjects Achieving Low Disease Activity

    Defined as Disease Activity Score 28 (DAS28) (CRP) < 3.2, and remaining on randomized treatment and in the study at Week 12.

    Measured: at Week 12

  2. Improvement of Physical Ability From Baseline to Week 12, as Measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)

    Change of physical ability from baseline (the last available assessment prior to the first dose of the study treatment) to week 12, as measured by HAQ-DI. The HAQ-DI total score ranges from 0 (the best outcome) to 3 (the worst outcome).The HAQ-DI assesses the degree of difficulty experienced in 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, common daily activities) of daily living activities using 20 questions. Each domain consists of 2 or 3 items. For each question the level of difficulty is scored from 0 (without any difficulty, the best outcome) to 3 (unable to do, the worst outcome). Each category is given a score by taking the maximum score of each question. The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. If fewer than 6 categories had responses, no disability score was calculated.

    Measured: Baseline to Week 12

  3. Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response

    A responder was defined as any subject satisfying ACR50 criteria and remaining on randomized treatment and in the study at Week 24.

    The calculations were based on a ≥ 50% improvement from baseline in the swollen joint count (SJC) assessed in 66 joints and in the tender joint count (TJC) assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (Visual Analog Scale (VAS) assessment), Patient Assessment of Pain (VAS assessment), Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician Global Assessment (VAS assessment), Level of acute phase reactant (CRP or ESR, using level of CRP in this study).

    Measured: at Week 24

  4. Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 (Remission)

    Percentage of subjects with Clinical Disease Activity Index (CDAI) ≤ 2.8 (remission) and remaining on randomized treatment and in the study at Week 24

    Measured: at Week 24

Timeline

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

  1. First posted3 May 2016 (estimated)
  2. Study start19 May 2016
  3. Primary completionAug 2018
  4. Study completionOct 2018

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
Double blind
Who is masked
Participant, Investigator
Enrolment
428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760368
Sponsor's protocol ID
CL04041022
Other IDs
2014-004719-36, 2014
Acronym
CREDO 1
Status last verified
Sep 2023
First submitted
29 Apr 2016
Last updated
21 Sep 2023
Data monitoring committee
Yes

Publications

  • Fleischmann RM, Strand V, Feist E, Lisitsyna T, Sparks JA, Nasonov E, Samsonov M, Grishin S, Egorova A, Kuzkina S, Smolen JS. Olokizumab Improves Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis up to 106 Weeks (Results from the Open-Label Extension of Phase III Randomized Clinical Trials). Rheumatol Ther. 2026 Aug;13(4):1055-1074. doi: 10.1007/s40744-026-00852-3. Epub 2026 May 16.

    PubMed 42142212

  • Nasonov E, Fatenejad S, Feist E, Ivanova M, Korneva E, Krechikova DG, Maslyanskiy AL, Samsonov M, Stoilov R, Zonova EV, Genovese M. Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study. Ann Rheum Dis. 2022 Apr;81(4):469-479. doi: 10.1136/annrheumdis-2021-219876. Epub 2021 Aug 3.

    PubMed 34344706

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olokizumab in people with Rheumatoid Arthritis, run by R-Pharm International, LLC at 40 sites in 3 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 10 inclusion and 41 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Russia, Bulgaria, Belarus. 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 Oct 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?

Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response (time frame: at Week 12). 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 NCT02760368, 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 21 Sep 2023.

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