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Rheumatoid ArthritisPhase 3SOLARNCT04227366

Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

A Phase 3 study testing BCD-089 and Methotrexat in people with Rheumatoid Arthritis, run by Biocad at 1 site in Russia.

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-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor. The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with active rheumatoid arthritis resistant to monotherapy with methotrexate. 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?
BCD-089 and Methotrexat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
1 siteRussia
Study dates
19 Nov 2019to 1 Mar 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form (ICF).
  • Men and women aged 18 years or older on the day of signing the ICF.
  • Verified rheumatoid arthritis according to the ACR 2010 criteria diagnosed at least 24 weeks before signing the ICF .
  • Use of methotrexate for the last 12 weeks before signing the ICF.
  • Use of a stable dose of methotrexate for the last 4 weeks before signing the ICF (the dose of methotrexate should be 15 to 25 mg per week). Methotrexate can be used at a dose of 10 mg in the case of intolerability/toxicity of higher doses.
  • Inefficacy of methotrexate used for the last 12 weeks before signing the ICF (in the opinion of the Investigator).
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  • Active rheumatoid arthritis at randomization in the study.
  • The ability of the patient (in the Investigator's opinion) to follow the Protocol procedures.
  • Patients and their sexual partners of childbearing potential agree to use reliable contraceptive methods starting from signing the ICF, during the study and for 8 weeks from the last injection of the investigational product. This requirement does not apply to patients and their partners who underwent surgical sterilization and to women who are post-menopausal for at least 2 years. Reliable contraceptive methods include one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives.

Who cannot join

  • Previous exposure to tocilizumab or other anti-IL6 or anti-IL-6R monoclonal antibodies.
  • Previous exposure to JAK inhibitors.
  • Previous exposure to rituximab or other B-cell depleting/suppressing agents.
  • Felty's syndrome (regardless of clinical form).
  • Patient's functional status: class IV according to the ACR 1991 classification.
  • Known allergy to or intolerance of any ingredients of BCD-089 or placebo.
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  • Use of any of the following concomitant therapies:
  • Oral prednisolone or its equivalent in a dose more than 10 mg/day;
  • Need in oral prednisolone (or its equivalent) ≤ 10 mg if its dose was not stable during the last 4 weeks before signing the ICF (patients who used topical glucocorticoids are allowed to participate in the study);
  • Need in NSAIDs if the dose was not stable during the last 4 weeks before signing the ICF (patients who have occasionally used NSAIDs for fever or allergy syndrome associated with an intercurrent disease can be included in the study);
  • Use of alkylating agents any time within 12 months before signing the ICF.
  • Intra-articular use of corticosteroids within 4 weeks before signing the ICF.
  • Vaccination with live or attenuated vaccines any time within 8 weeks before signing the ICF.
  • Use of leflunomide within 8 weeks before signing the ICF.
  • Use of TNFα inhibitors or T-cell costimulation blockers within 8 weeks before signing the ICF.
  • Any of the following laboratory values at screening:
  • Hemoglobin level < 80 g/L;
  • Leukocyte count < 3.0 × 109/L;
  • Platelet count < 100 × 109/L;
  • Neutrophil count < 2 × 109/L;
  • AST and ALT ≥ 1.5×ULN (based on the reference limits used by the laboratory);
  • Serum creatinine ≥ 1.7 × ULN (based on the reference limits used by the laboratory).
  • Positive pregnancy urine test in female subjects at screening (no test is required in women who are post-menopausal for at least 2 years and in surgically sterile women).
  • Current diagnosis or a history of a severe immunodeficiency of any other origin.
  • Diagnosed HIV, hepatitis B, hepatitis C, or syphilis ;
  • Tuberculosis now or in the past.
  • Latent TB forms (positive Diaskintest®, QuantiFERON®-TB Gold or T-SPOT.TB test with no radiographic signs of pulmonary TB).
  • Herpes zoster infection now or in the past .
  • Documented chickenpox within 30 days before signing the ICF.
  • Definite diagnosis of any other chronic infection (e.g. sepsis, invasive mycoses, histoplasmosis, etc.) that, in the Investigator's opinion, can increase the risk of infectious complications.
  • Any acute infection or aggravation of a chronic infection within 30 days before signing the ICF if this condition may, in the Investigator's opinion, increase the risk of infectious complications.
  • Severe infections (including those that required hospitalization or parenteral antibacterial/antimycotic/antiprotozoal treatment) within 6 months before signing the ICF.
  • Systemic antibacterial/antimycotic/antiprotozoal treatments used within 8 weeks before the signing the ICF.
  • More than 4 episodes of respiratory infections within 6 months before signing the ICF.
  • A major surgery within 30 days before signing the ICF or a major surgery scheduled at any time during the study.
  • History of epileptic attacks or seizures.
  • History of severe depression, suicidal thoughts or suicide attempts .
  • Diverticulosis and/or diverticulitis .
  • Alcohol, drug or psychoactive substance dependence or medication abuse now or in the past, signs of alcohol/drug dependence.
  • Other documented medical conditions that can increase a risk of adverse events during the study treatment, affect the assessment of the main disease severity, mask, aggravate, affect symptoms of the main disease, or result in the same clinical and laboratory instrumental symptoms as those of rheumatoid arthritis:
  • Diabetes mellitus with inadequate glycemic control ;
  • Severe treatment-resistant hypertension ;
  • Current or a history of inflammatory joint diseases other than rheumatoid arthritis (including ankylosing spondylitis, gout, psoriatic arthritis, Lyme disease etc. ) or other systemic autoimmune diseases (including systemic lupus erythematosus, Crohn's disease, non-specific ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, fibromyalgia etc.);
  • Malignant neoplasms except for cured basal-cell carcinoma and cancer of the cervix in situ (complete remission ≥ 5 years); cured basal-cell carcinoma of the skin (complete remission ≥ 5 years); cured ductal breast cancer (complete remission ≥ 5 years);
  • Decompensated liver or kidney diseases;
  • Unstable angina;
  • Chronic heart failure of NYHA class III-IV;
  • Myocardial infarction within 1 year before signing the ICF;
  • History of organ transplantation;
  • History of angioedema;
  • Respiratory system disorders with decompensated respiratory insufficiency;
  • Definite diagnosis of multiple sclerosis, Devic's disease, or Guillain-Barre syndrome;
  • Nervous system disorders with motor and/or sensitivity abnormalities.
  • Pregnancy , planned pregnancy less than 8 weeks after the last injection of the investigational product; lactation.
  • Current participation in other clinical studies; previous participation in other clinical studies within 3 calendar months before signing the ICF (except for screenouts); previous participation in this study (except for screenouts).

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Research Institute of Rheumotology

    Moscow

Other trials in Russia

About this study

Official title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor.

The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with active rheumatoid arthritis resistant to monotherapy with methotrexate.

Read the detailed description

BCD-089-3/SOLAR is the international, multicenter, double blind, placebo-controlled phase III clinical study.

The main period of the study (Weeks 0-24) is blinded; study subjects will receive BCD-089/placebo.

At Week 24 the study will become open-label and all patients will receive BCD-089 once a week for 4 weeks. At week 28 patients who achieved the RA remission at week 24 will be switched to BCD-089 Q2W dosing regimen and will receive it through Week 51. Patients who failed to achieve remission at week 24 will receive BCD-089 once a week through Week 51.

Being tested
BCD-089, Placebo, Methotrexat
Keywords
anti-IL-6R, IL-6 receptor inhibitors
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-089Biological

    BCD-089 162 mg SC

  • PlaceboBiological

    Also called Placebo (for BCD-089)

    Placebo

  • MethotrexatDrug

    15 to 25 mg/week

Study groups in NCT04227366
Study groupRoleWhat they receive
Group 1ExperimentalBCD-089
Receives: Biological: BCD-089; Drug: Methotrexat
Group 2Placebo comparatorPlacebo
Receives: Biological: Placebo; Drug: Methotrexat

What is being measured

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

  1. ACR 20 response

    The proportion of ACR 20 responders

    Measured: Week 12

  2. Low disease activity

    The proportion of patients with low disease activity according to DAS28-CRP(4) (< 3,2)

    Measured: Week 24

Secondary outcomes (22)

  1. Need for rescue therapy

    The proportion of patients who required rescue therapy

    Measured: Week 12.

  2. RA remission

    The proportion of patients who achieved RA remission according to DAS28-CRP(4) (< 2.6)

    Measured: Weeks 4, 8, 12, 16, 24.

  3. RA remission

    The proportion of patients who achieved RA remission according to CDAI (≤ 2.8)

    Measured: Weeks 4, 8, 12, 16, 24.

  4. RA remission

    The proportion of patients who achieved RA remission according to SDAI (≤ 3.3)

    Measured: Weeks 4, 8, 12, 16, 24.

  5. Remission according to the ACR/EULAR 2011 criteria

    The proportion of patients who achieved remission

    Measured: Weeks 4, 8, 12, 16, 24

  6. ACR20 response

    The proportion of ACR20 responders

    Measured: Weeks 4, 8, 16, 24

  7. ACR50 response

    The proportion of ACR50 responders

    Measured: Weeks 4, 8, 12, 16, 24

  8. ACR70 response

    The proportion of ACR70 responders

    Measured: Weeks 4, 8, 12, 16, 24

  9. Low RA activity according to DAS28-ESR(4)

    The proportion of patients who achieved low RA activity according to DAS28-ESR(4) (< 3.2)

    Measured: Weeks 4, 8, 12, 16, 24

  10. Low RA activity according to CDAI

    the proportion of patients who achieved low RA activity according to CDAI (≤ 10)

    Measured: Weeks 4, 8, 12, 16, 24.

  11. Low RA activity according to SDAI

    The proportion of patients who achieved low RA activity according to SDAI (≤ 11)

    Measured: Weeks 4, 8, 12, 16, 24.

  12. Change in the DAS28-CRP(4)

    The change from baseline in the DAS28-CRP(4)

    Measured: Weeks 4, 8, 12, 16, 24.

  13. Change in the CDAI

    The change from baseline in the CDAI

    Measured: Weeks 4, 8, 12, 16, 24.

  14. Change in the SDAI

    The change from baseline in the SDAI

    Measured: Weeks 4, 8, 12, 16, 24.

  15. Moderate/good response according to the EULAR criteria

    The proportion of patients with moderate/good response according to the EULAR criteria

    Measured: Weeks 4, 8, 12, 16, 24

  16. Change in concentration of C-reactive protein

    The change from baseline in the concentration of C-reactive protein in serum

    Measured: Weeks 4, 8, 12, 16, 24.

  17. Change in the ESR

    The change from baseline in the erythrocyte sedimentation rate (ESR)

    Measured: Weeks 4, 8, 12, 16, 24

  18. Change in the quality of life measured with SF-36

    The change from baseline in the patient's quality of life measured with the SF-36 score

    Measured: Weeks 12, 24

  19. Change in the quality of life measured with the EQ-5D-3L

    The change from baseline in the patient's quality of life measured with the EQ-5D-3L

    Measured: Weeks 12, 24

  20. Change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score

    The change in the FACIT-F score. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued) (Webster et al., 2003)

    Measured: Weeks 12, 24

  21. Change in functional activity

    The change in functional activity according to the HAQ-DI (Health Assessment Questionnaire without Didability Index) score. The value of the HAQ-DI index can be interpreted in terms of three categories:

    from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.

    Measured: Weeks 12, 24

  22. X-ray assessment

    The change in mTSS score according to Sharp/van der Heijde (SvH) scoring method

    Measured: 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 posted13 Jan 2020
  2. Study start19 Nov 2019
  3. Primary completion15 Mar 2021
  4. Study completion1 Mar 2022

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
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04227366
Sponsor's protocol ID
BCD-089-3
Acronym
SOLAR
Status last verified
Nov 2020
First submitted
25 Dec 2019
Last updated
12 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mazurov V.I., Korolev M.A., Prystrom A.M., Kunder E.V., Soroka N.F., Kastanayan A.A., Povarova T.V., Plaksina T.V., Antipova O.V., Kretchikova D.G., Smakotina S.A., Tciupa O.A., Puntus E.V., Raskina T.A., Shilova L.N., Kropotina T.V., Nesmeyanova O.B., Popova T.A., Vinogradova I.B., Linkova Yu.N., Dokukina E.A., Plotnikova A.V., Pukhtinskaia P.S., Zinkina-Orikhan A.V., Eremeeva A.V., Lutckii A.A. Effectiveness and safety of levilimab in combination with methotrexate in treatment of patients with active rheumatoid arthritis resistant to methotrexate monotherapy (double-blinded randomized placebo controlled phase III clinical study SOLAR). Modern Rheumatology Journal. 2021;15(4):13-23. https://doi.org/10.14412/1996-7012-2021-4-13-23

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-089 and Methotrexat in people with Rheumatoid Arthritis, run by Biocad at 1 site in Russia.

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 9 inclusion and 55 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 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. 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?

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?

ACR 20 response (time frame: Week 12). The study lists 2 primary outcomes in all. 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 NCT04227366, 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 12 May 2022.

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