Clinical trial NCT02762838: Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Ratio of patients with ACR20 response after 14 weeks of therapy
timeFrame: Week 14
Secondary outcomes:
measure: Ratio of patients with ACR20 response after 30 and 54 weeks of therapy
timeFrame: Week 30, Week 54
measure: Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Ratio of patients with low activity of rheumatoid arthritis according to index DAS28-CRP(4) after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Ratio of patients with low activity of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Ratio of patients with low activity of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Ratio of patients with remission of rheumatoid arthritis according to index DAS28 after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Ratio of patients with remission of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Ratio of patients with remission of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Ratio of patients with remission of rheumatoid arthritis according to ACR-EULAR criteria after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy
timeFrame: Screening, Week 14, Week 30, Week 54
measure: CRP
timeFrame: Screening, Week 14, Week 30, Week 54
measure: ESR
timeFrame: Screening, Week 14, Week 30, Week 54
measure: Roentgenologic characteristics of abnormal joints after 54 weeks of therapy
timeFrame: Week 54
measure: Frequency of AE/SAE
timeFrame: 54 weeks
measure: Frequency of AE 3-4 grade CTCAE
timeFrame: 54 weeks
measure: Frequency of early withdrawals due to AE/SAE
timeFrame: 54 weeks
measure: Percentage of patients who developed binding and neutralizing antibodies to infliximab
timeFrame: Screening, Week 14, Week 30, Week 54
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institution of Healthcare "9th Municipal Clinical Hospital"
city: Minsk
country: Belarus
facility: Institution of Healthcare "First Municipal Clinical Hospital"
city: Minsk
country: Belarus
facility: Institution of Healthcare "Ordena Trudovogo Krasnogo Znameni Regional Clinical Hospital"
city: Vitebsk
country: Belarus
facility: Institution of Healthcare "Clinical Hospital of Vitebsk Region"
city: Ahmedabad
country: India
facility: Shalby Hospital
city: Bangalore
country: India
facility: Sapthagiri Institute of Medical Sciences and Research Centre
city: Bīkaner
country: India
facility: S.P Medical College & A.G. of Hospitals
city: Kolkata
country: India
facility: Apollo Gleneagles Hospital
city: Pune
country: India
facility: Noble Hospital
city: Pune
country: India
facility: Ruby Hall Clinic
city: Barnaul
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University"
city: Belgorod
country: Russian Federation
facility: Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University"
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital"
city: Irkutsk
country: Russian Federation
facility: Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1"
city: Kemerovo
country: Russian Federation
facility: State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital"
city: Khanty-Mansiysk
country: Russian Federation
facility: Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital"
city: Krasnodar
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1
city: Kursk
country: Russian Federation
facility: Budgetary Medical Institution "Kursk Regional Clinical Hospital"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology"
city: Moscow
country: Russian Federation
facility: State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department
city: Nizhny Novgorod
country: Russian Federation
facility: Private Institution of Healthcare "Railway Clinical Hospital at Nizhniy Novgorod Station of Russian Railways Open-Joint Stock Company"
city: Nizhny Novgorod
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Nizhniy Novgorod Region "N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital"
city: Novosibirsk
country: Russian Federation
facility: State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1
city: Omsk
country: Russian Federation
facility: Budgetary Institution of Healthcare of Omsk Region "Regional Clinical Hospital"
city: Petrozavodsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital"
city: Rostov-on-Don
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "I. I. Mechnikov North-West State Medical University"
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company Baltic Medicine
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company BioEq
city: Saint Petersburg
country: Russian Federation
facility: Private Medical Institution Evromedservis
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Institution of Healthcare "Clinical Rheumatological Hospital 25"
city: Saint Petersburg
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Leningrad Region Clinical Hospital"
city: Saratov
country: Russian Federation
facility: Non-state Healthcare Institution "Road Clinical Hospital at Saratov II Station of Russian Railways Open Joint-Stock Company"
city: Saratov
country: Russian Federation
facility: State Institution of Healthcare "Regional Clinical Hospital"
city: St.Petersburg
country: Russian Federation
facility: North-Western State Medical University n.a. I.I.Mechnikov
city: Tomsk
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"
city: Tyumen
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1"
city: Volgograd
country: Russian Federation
facility: State Institution of Healthcare "Municipal Clinical Emergency Hospital 25"
Study officials:
affiliation: JSC BIOCAD
name: Roman Ivanov, PhD
role: STUDY_CHAIR
References:
citation: 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.