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Rheumatoid ArthritisPhase 3NCT02762838

Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

A Phase 3 study testing BCD-055, Remicade® and Methotrexate in people with Rheumatoid Arthritis, run by Biocad at 39 sites in 3 countries.

Completed

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

Official record
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Trial summary

BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid arthritis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
BCD-055, Remicade® and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
426 participants
Where
39 sitesin 3 countries
Study dates
Jan 2016to Jul 2018
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Active rheumatoid arthritis according to criteria of American College of Rheumatologists (2010), that was diagnosed at least 6 months prior to screening.
  • Active rheumatoid arthritis at screening despite of therapy with methotrexate for 3 last months.
  • Use of methotrexate in stable dose for at least 4 weeks before screening (10-25 mg per week).
  • History of ineffective treatment with basic antiinflammatory drugs (including methotrexate).

Who cannot join

  • Previous therapy of rheumatoid arthritis with monoclonal antibodies (including anti-tumor necrosis factor drugs)
  • Felty's syndrome
  • Functional status - class IV according to ACR classification (1991)
  • Low activity of rheumatoid arthritis (DAS28-CRP(4) index less than 3.2)
  • Patient needs corticosteroids in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent.
  • Patients needs equal of less than 10 mg prednisolone but the dose was not stable for last 4 weeks prior to infliximab treatment
Show all 12Show fewer
  • Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization.
  • Prior use of alkylating agents for up to 12 months prior to signing informed consent.
  • Intraarticular use of corticosteroids for up to 4 weeks before randomization.
  • Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
  • Diagnosis of tuberculosis.
  • Body mass more than 130 kg.

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

Russia29 sites

  • Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University"

    Barnaul

  • Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University"

    Belgorod

  • State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital"

    Chelyabinsk

  • Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1"

    Irkutsk

  • State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital"

    Kemerovo

  • Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital"

    Khanty-Mansiysk

  • State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1

    Krasnodar

  • Budgetary Medical Institution "Kursk Regional Clinical Hospital"

    Kursk

  • Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology"

    Moscow

  • State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

    Moscow

  • State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department

    Moscow

  • Private Institution of Healthcare "Railway Clinical Hospital at Nizhniy Novgorod Station of Russian Railways Open-Joint Stock Company"

    Nizhny Novgorod

  • State Budgetary Institution of Healthcare of Nizhniy Novgorod Region "N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital"

    Nizhny Novgorod

  • State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1

    Novosibirsk

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

    Omsk

  • State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital"

    Petrozavodsk

  • Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"

    Rostov-on-Don

  • Federal State Budgetary Educational Institution of Higher Education "I. I. Mechnikov North-West State Medical University"

    Saint Petersburg

  • Limited Liability Company Baltic Medicine

    Saint Petersburg

  • Limited Liability Company BioEq

    Saint Petersburg

  • North-Western State Medical University n.a. I.I.Mechnikov

    Saint Petersburg

  • Private Medical Institution Evromedservis

    Saint Petersburg

  • Saint Petersburg State Budgetary Institution of Healthcare "Clinical Rheumatological Hospital 25"

    Saint Petersburg

  • State Budgetary Institution of Healthcare "Leningrad Region Clinical Hospital"

    Saint Petersburg

  • Non-state Healthcare Institution "Road Clinical Hospital at Saratov II Station of Russian Railways Open Joint-Stock Company"

    Saratov

  • State Institution of Healthcare "Regional Clinical Hospital"

    Saratov

  • Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"

    Tomsk

  • State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1"

    Tyumen

  • State Institution of Healthcare "Municipal Clinical Emergency Hospital 25"

    Volgograd

Other trials in Russia

India6 sites

  • Shalby Hospital

    Ahmedabad

  • Sapthagiri Institute of Medical Sciences and Research Centre

    Bangalore

  • S.P Medical College & A.G. of Hospitals

    Bīkaner

  • Apollo Gleneagles Hospital

    Kolkata

  • Noble Hospital

    Pune

  • Ruby Hall Clinic

    Pune

Other trials in India

Belarus4 sites

  • Institution of Healthcare "9th Municipal Clinical Hospital"

    Minsk

  • Institution of Healthcare "First Municipal Clinical Hospital"

    Minsk

  • Institution of Healthcare "Ordena Trudovogo Krasnogo Znameni Regional Clinical Hospital"

    Minsk

  • Institution of Healthcare "Clinical Hospital of Vitebsk Region"

    Vitebsk

Other trials in Belarus

About this study

Official title: International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid arthritis.

Being tested
BCD-055, Remicade®, 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.

  • BCD-055Biological

    Also called infliximab

    BCD-055 is infliximab biosimilar

  • Remicade®Biological

    Also called infliximab

  • MethotrexateDrug

    All patients will receive methotrexate in a dose from 10 to 25 mg per week.

  • Folic acidDrug

    All patients will receive folic acid in a dose of 5 mg per week.

Study groups in NCT02762838
Study groupRoleWhat they receive
BCD-055ExperimentalPatients in this group will receive BCD-055 in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54.
Receives: Biological: BCD-055; Drug: Methotrexate; Drug: Folic acid
Remicade®Active comparatorPatients in this group will receive Remicade® in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54.
Receives: Biological: Remicade®; Drug: Methotrexate; Drug: Folic acid

What is being measured

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

  1. Ratio of patients with ACR20 response after 14 weeks of therapy

    Ratio of patients who developed a decrease in American College of Rheumatologists (ACR) score by 20% or more after 14 weeks of therapy with study drug

    Measured: Week 14

Secondary outcomes (17)

  1. Ratio of patients with ACR20 response after 30 and 54 weeks of therapy

    Ratio of patients who developed a decrease in American College of Rheumatologists (ACR) score by 20% or more after 30 and 54 weeks of therapy with study drug

    Measured: Week 30, Week 54

  2. Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy

    Ratio of patients who developed a decrease in American College of Rheumatologists (ACR) score by 50% or more and by 70% or more after 14, 30 and 54 weeks of therapy with study drug

    Measured: Week 14, Week 30, Week 54

  3. Ratio of patients with low activity of rheumatoid arthritis according to index DAS28-CRP(4) after 14, 30 and 54 weeks of therapy

    Ratio of patients with low activity of rheumatoid arthritis according to index Disease Activity Score 28 - C-reactive protein (DAS28-CRP(4), score 2.6-3.2) after 14, 30 and 54 weeks of therapy.

    Measured: Week 14, Week 30, Week 54

  4. Ratio of patients with low activity of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy

    Ratio of patients with low activity of rheumatoid arthritis according to Clinical Disease Activity Index (CDAI, score 2.9-10.0) after 14, 30 and 54 weeks of therapy.

    Measured: Week 14, Week 30, Week 54

  5. Ratio of patients with low activity of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy

    Ratio of patients with low activity of rheumatoid arthritis according to Simplified Disease Activity Index (SDAI, score 3.4-11.0) after 14, 30 and 54 weeks of therapy.

    Measured: Week 14, Week 30, Week 54

  6. Ratio of patients with remission of rheumatoid arthritis according to index DAS28 after 14, 30 and 54 weeks of therapy

    Ratio of patients with remission of rheumatoid arthritis according to index Disease Activity Score 28 (DAS28, score less than 2.6) after 14, 30 and 54 weeks of therapy.

    Measured: Week 14, Week 30, Week 54

  7. Ratio of patients with remission of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy

    Ratio of patients with remission of rheumatoid arthritis according to Clinical Disease Activity Index (CDAI, score 0.0-2.8) after 14, 30 and 54 weeks of therapy.

    Measured: Week 14, Week 30, Week 54

  8. Ratio of patients with remission of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy

    Ratio of patients with remission of rheumatoid arthritis according to Simplified Disease Activity Index (SDAI, score 0.0-3.3) after 14, 30 and 54 weeks of therapy.

    Measured: Week 14, Week 30, Week 54

  9. Ratio of patients with remission of rheumatoid arthritis according to ACR-EULAR criteria after 14, 30 and 54 weeks of therapy

    Ratio of patients with low activity of rheumatoid arthritis according to American College of Rheumatologists (ACR)/ European league Against Rheumatism (EULAR) after 14, 30 and 54 weeks of therapy.

    Measured: Week 14, Week 30, Week 54

  10. Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy

    Mean score of quality of life as assessed by Short Form-36 (SF-36) at screening and after 14, 30 and 54 weeks of therapy.

    Measured: Screening, Week 14, Week 30, Week 54

  11. CRP

    Dynamics of blood level of C-reactive protein (CRP)

    Measured: Screening, Week 14, Week 30, Week 54

  12. ESR

    Dynamics of Erythrocyte Sedimentation Rate

    Measured: Screening, Week 14, Week 30, Week 54

  13. Roentgenologic characteristics of abnormal joints after 54 weeks of therapy

    Measured: Week 54

  14. Frequency of AE/SAE

    Measured: 54 weeks

  15. Frequency of AE 3-4 grade CTCAE

    Measured: 54 weeks

  16. Frequency of early withdrawals due to AE/SAE

    Measured: 54 weeks

  17. Percentage of patients who developed binding and neutralizing antibodies to infliximab

    Measured: Screening, Week 14, Week 30, Week 54

Timeline

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

  1. First posted5 May 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJul 2018
  4. Study completionJul 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
426 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02762838
Sponsor's protocol ID
BCD-055-3
Status last verified
Jun 2019
First submitted
4 Apr 2016
Last updated
14 Jun 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Lila AM, Mazurov VI, Denisov LN, Nesmeyanova OB, Ilivanova EP, Eremeeva AV, Usacheva JV, Dokukina EA, Chernyaeva EV, Ivanov RA. A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study. Rheumatol Int. 2019 Sep;39(9):1537-1546. doi: 10.1007/s00296-019-04359-9. Epub 2019 Jul 10.

    PubMed 31292709

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-055, Remicade® and Methotrexate in people with Rheumatoid Arthritis, run by Biocad at 39 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 5 inclusion and 12 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Russia, India, 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Ratio of patients with ACR20 response after 14 weeks of therapy (time frame: Week 14). 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 NCT02762838, 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 Jun 2019.

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Clinical Trial NCT02762838 | AzTrials