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Rheumatoid ArthritisPhase 2NEXUSNCT02379091

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

A Phase 2 study testing Namilumab, Methotrexate and Folic/folinic acid in people with Rheumatoid Arthritis, run by Takeda at 31 sites in 8 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 is to establish proof of concept and identify the optimal efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor (TNF)-inhibitor (TNF-IR). 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?
Namilumab, Methotrexate and Folic/folinic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
31 sitesin 8 countries
Study dates
17 Dec 2014to 5 Dec 2016
Phase
Phase 2
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

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • Is male or female and aged 18 years (20 years in Japan) or older (65 years maximum in Czech Republic) at time of signing the informed consent form.
  • Must have adult onset rheumatoid arthritis (RA) as defined by the 2010 American College of Rheumatology (ACR)/ European League against Rheumatism (EULAR) criteria for the classification of RA for at least 6 months prior to Screening Visit.
  • Must have active disease defined as:
  • At least moderately active disease defined by Disease Activity Score 28 based on C-reactive protein [DAS28(CRP)] ≥3.2 at screening and Disease Activity Score 28 based on Erythrocyte Sedimentation Rate [DAS28(ESR)] ≥3.2 at baseline visit [Day 1] and Swollen joint count (SJC) ≥4 (within the 28 joints from DAS28) at both the Screening and baseline [Day 1] Visits.
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  • Visual analog scale (VAS) pain >40 mm as measured using the 100 mm study site electronic VAS scale at the Screening Visit and baseline [Day 1] Visits.
  • Currently receiving treatment for Rheumatoid Arthritis (RA) with methotrexate (MTX), and:
  • Has received MTX on a weekly basis for at least 3 months prior to the Baseline (Day 1) Visit AND;
  • Has received treatment with 15 mg/week ≤MTX ≤25 mg/week (6 mg/week ≤MTX ≤16 mg/week in Japan) at a stable dose via the same route of administration and formulation for at least 8 weeks prior to Baseline [Day 1] Visit
  • OR:
  • For participants outside Japan, a stable dose for at least 8 weeks of MTX of ≥7.5 mg/week is acceptable, if the MTX dose has been reduced for reasons of documented intolerance to MTX, e.g. hepatic or hematological toxicity documented in Electronic case report form (eCRF), or per local requirement.
  • Willing to continue or initiate treatment with oral folic acid (at least 5 mg/week) or equivalent and be treated during the entire study (mandatory co-medication for MTX treatment).
  • Must have a posterior, anterior (PA) and lateral chest x-ray obtained within 3 months prior to Screening, or recorded during screening.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study until the end of the safety follow up (18 weeks after last dose).
  • A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of the informed consent throughout the duration of the study until the end of the safety follow up (18 weeks after last dose).
  • Is able and willing to complete questionnaires at home using an electronic device in an approved language.
  • Has either Inadequate response to methotrexate (MTX-IR) or Inadequate response to TNF-inhibitor (TNF-IR).

Who cannot join

  • Participants <18 years of age (<20 years in Japan) or less than the legal adult age in the country of the study site, whichever is higher. Participants >65 years of age in Czech Republic.
  • Has received any investigational compound within 30 days, or within 5 half lives (whichever is longer) prior to the Screening Visit, or is participating or plans to participate in any other clinical study during this study.
  • Has a history of or currently has any inflammatory joint disease other than RA (eg, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy or Lyme disease) or other systemic autoimmune disorder (eg, systemic lupus erythematosus [SLE], inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome).
  • Has any major systemic features of RA, eg, Felty's syndrome, vasculitis or interstitial fibrosis of the lungs.
  • Has a diagnosis of primary fibromyalgia that would make it difficult to appropriately assess RA activity for the purposes of this study.
  • History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
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  • Is required to take or has taken excluded medications.
  • Has any of the following laboratory abnormalities at the screening visit (identified by the central laboratory):
  • Hemoglobin <8.5 g/dL;
  • Neutrophils <1500/mm^3;
  • Platelet count <75000 cells/mm^3;
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN);
  • Bilirubin (total) >ULN, unless Gilbert's disease has been determined by genetic testing and has been documented.
  • 9. Has a history of hypersensitivity or allergies to any of the contents of the formulation.
  • 10. Has any clinically significant illness, including infection requiring antibiotics, within 4 weeks prior to the first dose of study medication, which may influence the outcome of the study.
  • 11. Has an underlying condition that predisposes to infections (eg, immunodeficiency, poorly controlled diabetes history, splenectomy).
  • 12. Evidence of clinically significant respiratory disease, on the basis of review the data from participants' respiratory assessments, including chest x-ray, lung function tests (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) by spirometry performed at screening). The participants must have Saturation of peripheral oxygen (SpO2) ≥94%, FEV1 and FVC ≥60 % of predicted values and a Medical Research Council (MRC) Breathlessness Scale score of less than 4 at Screening and at Baseline and no uncontrolled lung disease. A participant's treatment which has been modified to control lung disease within 24 weeks prior to screening is exclusionary.
  • 13. History of clinically significant interstitial lung disease (ILD) eg, history of chronic or recurrent pulmonary infection where macrophages are important for the clearance of the infection eg, pneumocystis jiroveci pneumonia (PJP) formerly known as pneumocystis carinii pneumonia (PCP), allergic bronchopulmonary aspergillosis (ABPA), nocardia infections, Actinomyces infection, Japanese and Korean participants will be tested using Beta glucans test and participants will be excluded unless the Beta-Glucans test is negative.
  • 14. Presence or history of active tuberculosis (TB) or latent TB infection, where no anti-TB treatment has been given or where successful completion of an appropriate course of anti-TB therapy cannot be documented.
  • 15. A positive QuantiFERON-TB Gold test and/or evidence of active or latent TB by chest X-ray, not accompanied by initiation of an approved regimen of anti-TB therapy at least 12 months prior to the Baseline visit.
  • 16. Has a known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus, or has serological findings at the Screening Visit which indicate active or latent hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  • (Japan only) Participant has a positive result for hepatitis B virus surface antigen (HBsAg), hepatitis B virus antibody [hepatitis B surface antibody (HBs antibody) / hepatitis B virus core antibody (HBc antibody)], hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody. However, participants who are HBs antibody solely positive (but HBsAg and HBc antibody negative), resulting from hepatitis B virus (HBV) vaccination, are not to be excluded from the study.
  • 17. Has a history of severe chronic obstructive pulmonary disease (COPD) and/or history of severe COPD exacerbation(s), or a history of asthma with exacerbations requiring hospitalization (including emergency or acute care treatments), within the last 12 months prior to the Screening visit.
  • 18. History of MTX-associated lung toxicity. 19. Has a history or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the investigator and/or Medical Monitor would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
  • 20. Any significant cardiac disease (eg, coronary artery disease with unstable angina, coronary heart failure New York Heart Association [NYHA] Class III and IV, familial long QT syndrome).
  • 21. Has a history of treatment with anti-chemotherapy (eg, alkylating agents, anti-metabolites [except MTX and Azathioprine], and purine analogues) and/or anti-cancer monoclonal antibodies within the last 5 years with the exception of topical anticancer drugs used in the treatment of basal or squamous cell carcinoma of the skin or pre-cancerous skin lesions.
  • 22. Has a history of cancer within the last 10 years except for basal cell or squamous cell carcinomas of the skin or in situ carcinoma of the cervix treated and considered cured.
  • 23. Has a history of drug abuse (defined as any illicit drug use), or a history of alcohol abuse within 2 years prior to the Screening visit.
  • 24. Has a severe psychiatric or neurological disorder. 25. If female, the participant is pregnant or lactating or intends to become pregnant before, during, or within 18 weeks after the last treatment visit; or intends to donate ova during such time periods.
  • 26. If male, the participant intends to donate sperm during or within 18 weeks after the last treatment visit.
  • 27. Has plans to donate germ cells, organs or bone marrow during the course of the study and within 6 months after the last injection of investigational medicinal product (IMP).
  • 28. Elective surgical procedure, including bone or joint surgery/ synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline visit, or if the participant plans to have elective surgical procedure during the study, or within 18 weeks after the last treatment visit.
  • 29. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee involved in conduct of this study (eg, spouse, parent, child, sibling), or may consent under duress.
  • 30. Is suspected to be unable or unwilling to adequately comply with study procedures eg, language problems.

Trial locations and contacts

31 sites in 8 countries.

31 sites in 8 countries

Japan13 sites

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Iizuka-shi, Fukuoka

  • Study site

    Kawasaki-shi, Kanagawa

  • Study site

    Kitakyusyu-shi, Fukuoka

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Miyagi-gun, Miyagi

  • Study site

    Morioka, Iwate

  • Study site

    Nagasaki, Nagasaki

  • Study site

    Nishimuro-gun, Wakayama

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sasebo-shi, Nagasaki

  • Study site

    Takarazuka-shi, Hyōgo

Other trials in Japan

Czechia4 sites

  • Study site

    České Budějovice

  • Study site

    Prague

  • Study site

    Uherské Hradiště

  • Study site

    Zlín

Other trials in Czechia

Russia4 sites

  • Study site

    Kazan'

  • Study site

    Saint Petersburg

  • Study site

    Ulyanovsk

  • Study site

    Voronezh

Other trials in Russia

Bulgaria3 sites

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sofia

Other trials in Bulgaria

Poland2 sites

  • Study site

    Bydgoszcz

  • Study site

    Torun

Other trials in Poland

Spain2 sites

  • Study site

    A Coruña

  • Study site

    Seville

Other trials in Spain

United Kingdom2 sites

  • Study site

    London, Greater London

  • Study site

    Romford, Essex

Other trials in United Kingdom

South Korea1 site

  • Study site

    Seoul, Gyeonggi-do

Other trials in South Korea

About this study

Official title: A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

The purpose of this study is to establish proof of concept and identify the optimal efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor (TNF)-inhibitor (TNF-IR).

Read the detailed description

The drug being tested in this study is called namilumab. Namilumab is being tested to treat rheumatoid arthritis (RA) in people who have an inadequate response to methotrexate, and in people who have an inadequate response to tumor necrosis factor-inhibitor (TNF-IR). This study will look at improvement in disease activity in participants who take namilumab.

The study will enroll approximately 100 patients. Participants will be randomly assigned (by chance) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Namilumab 20 mg/mL subcutaneous injection
  • Namilumab 80 mg/mL subcutaneous injection
  • Namilumab 150 mg/mL subcutaneous injection
  • Placebo (dummy inactive subcutaneous injection) - this is a medication that looks like the study drug but has no active ingredient.

All participants will receive namilumab or placebo as specified in the protocol. A stable dose of methotrexate and daily folic acid will also be required treatments.

This multi-centre trial will be conducted worldwide. The overall time to participate in this study is up to approximately 40 weeks. Participants will make multiple visits to the clinic, including a follow-up assessment up to 18 weeks after the last dose of study medication.

Being tested
Namilumab, Placebo, Methotrexate, Folic/folinic acid
Keywords
Drug therapy
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • NamilumabDrug

    Namilumab subcutaneous injection

  • PlaceboDrug

    Namilumab placebo-matching subcutaneous injection

  • MethotrexateDrug

    Methotrexate tablets

  • Folic/folinic acidDrug

    Folic/folinic acid tablets

Study groups in NCT02379091
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNamilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Receives: Drug: Placebo; Drug: Methotrexate; Drug: Folic/folinic acid
Namilumab 20 mg/mLExperimentalNamilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Receives: Drug: Namilumab; Drug: Methotrexate; Drug: Folic/folinic acid
Namilumab 80 mg/mLExperimentalNamilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Receives: Drug: Namilumab; Drug: Methotrexate; Drug: Folic/folinic acid
Namilumab 150 mg/mLExperimentalNamilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Receives: Drug: Namilumab; Drug: Methotrexate; Drug: Folic/folinic acid

What is being measured

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

  1. Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12

    The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A mixed model repeated measures (MMRM) model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.

    Measured: Baseline and Week 12

Secondary outcomes (6)

  1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24

    ACR20/50/70 response is defined as a ≥20/50/70% reduction from Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), and the following:

    • Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain
    • Patient's Global Assessment of Disease Activity
    • Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity
    • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do
    • Acute-phase reactant: C-reactive Protein (CRP).

    Measured: Baseline and Weeks 12 and 24

  2. ACR Numeric (N) Index (ACRn) at Week 12

    ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure.

    Measured: Baseline and Week 12

  3. ACR Numeric (N) Index (ACRn) at Week 24

    ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure.

    Measured: Baseline and Week 24

  4. Change From Baseline in DAS28-CRP at Weeks 2, 6, and 10

    The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.

    Measured: Baseline and Weeks 2, 6 and 10

  5. Change From Baseline in DAS28-CRP at Week 24

    The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement.

    Measured: Baseline and Week 24

  6. Percentage of Participants With a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) at Weeks 2, 12 and 24

    Reduction of Pain, defined as a ≥40% change from Baseline as measured using a 100 mm Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain at weeks 2, 12 and 24.

    Measured: Baseline and Week 2, 12 and 24

Timeline

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

  1. First posted4 Mar 2015 (estimated)
  2. Study start17 Dec 2014
  3. Primary completion11 May 2016
  4. Study completion5 Dec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02379091
Sponsor's protocol ID
M1-1188_202
Other IDs
U1111-1151-6931, 2013-002805-76, 14/SC/1252, 153300410A0071, JapicCTI-152979
Acronym
NEXUS
Status last verified
Aug 2018
First submitted
28 Nov 2014
Last updated
14 Sep 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Taylor PC, Saurigny D, Vencovsky J, Takeuchi T, Nakamura T, Matsievskaia G, Hunt B, Wagner T, Souberbielle B; NEXUS Study Group. Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an inadequate response or intolerance to an anti-TNF (tumour necrosis factor) biologic therapy: a randomized, controlled trial. Arthritis Res Ther. 2019 Apr 18;21(1):101. doi: 10.1186/s13075-019-1879-x.

    PubMed 30999929

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Namilumab, Methotrexate and Folic/folinic acid in people with Rheumatoid Arthritis, run by Takeda at 31 sites in 8 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 18 inclusion and 34 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 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Japan, Czechia, Russia, Bulgaria, Poland and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Sep 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?

Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12 (time frame: Baseline and 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 NCT02379091, which also lists 1 linked publication.

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 14 Sep 2018.

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