Rheumatoid ArthritisPhase 3NCT06475508
Comparison of Complarate® (Tocilizumab Biosimilar) and Actemra® in Patients With Rheumatoid Arthritis
A Phase 3 study testing Complarate® and Actemra® in people with Rheumatoid Arthritis, run by AO GENERIUM at 28 sites in Russia.
Trial summary
This is a randomized double-blind comparative parallel group study of the efficacy and safety of tocilizumab biosimilar Complarate® and Actemra® in the treatment of patients with rheumatoid arthritis with moderate to high disease activity. Participants received an intravenous dose of tocilizumab 8 mg/kg once 4 weeks. 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?
- Complarate® and Actemra®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 28 sitesRussia
- Study dates
- 13 Feb 2023to 11 Jun 2024
- 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
- Availability of written informed consent obtained from the patient before the start of any procedures related to the study.
- Men and women 18-75 years of age, inclusive, at the time of signing the informed consent form.
- Patients with a documented diagnosis of rheumatoid artritis (RA), established according to the 2010 ACR/EULAR classification criteria at least 6 months before screening, with moderate to high disease activity and an insufficient response to methotrexate monotherapy (maintaining moderate/high disease activity for at least 3 months) and/or poor tolerability of methotrexate (including the subcutaneous form of the drug) and/or insufficient response to or intolerance to other synthetic disease-modifying anti-inflammatory drugs (sDMARDs) in combination with methotrexate or without methotrexate.
- The number of swollen and/or painful joints is 6 or more.
- No changes in the dosage regimen of standard RA therapy with oral glucocorticosteroids and NSAIDs for ≥ 4 weeks before screening.
- No changes in the dosing regimen of standard RA sDMARD therapy for ≥ 4 weeks before screening.
- Agreement to adhere to adequate methods of contraception throughout the study and for 3 months after the end of tocilizumab therapy.
Who cannot join
- A history of rheumatic autoimmune disease other than rheumatoid arthritis.
- Functional Class IV according to the ACR Functional Status Classification or wheelchair/bedridden.
- Development of pronounced extra-articular (systemic) manifestations of the disease and complications (rheumatoid vasculitis, amyloidosis, Felty's syndrome, neuropathy, damage to the organ of vision).
- Use of oral corticosteroids in doses greater than >10 mg daily prednisolone equivalent, or change in oral corticosteroid dose within 4 weeks before or during screening.
- Use of injectable corticosteroids (including intra-articular corticosteroids) or intra-articular hyaluronic acid injections within 4 weeks before or during screening.
- Therapy with tumor necrosis factor-alfa (TNF-alpha) inhibitors or any other genetically engineered biological drugs within 1 month before screening.
Show all 23Show fewer
- History of tocilizumab therapy.
- Major surgery (including joint surgery) within 8 weeks before the start of the study or elective surgery within 6 months after the start of the study.
- A history of an adverse drug reaction to any of the components of the study drug or a reference drug.
- Immunization with any live or live attenuated vaccine within 1 month before the first dose of the study or comparator drug.
- A history of a disease associated with the accumulation of immune complexes (including serum sickness).
- Concomitant diseases and conditions that, in the opinion of the Investigator and/or Sponsor, jeopardize the safety of the patient during participation in the study, or which will influence the analysis of safety data.
- Active systemic infection (bacterial, viral or fungal) within 14 days before signing the informed consent form or at the time of screening.
- Blood donation or blood loss (450 ml of blood or more) less than 2 months before the start of the study.
- Pregnancy or breastfeeding.
- History of demyelinating disease of the central nervous system.
- History of diverticulosis/intestinal diverticulitis or chronic ulcerative diseases of the lower gastrointestinal tract, such as Crohn's disease, ulcerative colitis.
- History of tuberculosis.
- Positive/doubtful test with tuberculosis allergen.
- Participation in clinical trials of drugs less than 3 months before signing the informed consent form.
- Positive tests for hepatitis B or C, HIV or syphilis.
- Unwillingness or inability to comply with the recommendations prescribed by this protocol.
- Identification during screening of other diseases/conditions not listed above that, in the opinion of the physician-researcher, prevent the inclusion of the patient in the study.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Russia28 sites
State Budgetary Healthcare Institution Chelyabinsk area Clinical Hospital
Chelyabinsk, 454048
Limited Liability Company Research Medical Complex "Your Health"
Kazan', Tatarstan Republic, 420097
Limited Liability Company "Medical Center "Revma-Med"
Kemerovo, 650070
Limited Liability Company "Family Clinic No. 4"
Korolyov, Moscow Oblast, 141060
Limited Liability Company "OLLA-MED"
Moscow, 105554
State Budgetary Healthcare Institution MKSC named after A.S. Loginova Moscow Health Department
Moscow, 111123
Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova"
Moscow, 115522
Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov Ministry of Health of Russia
Moscow, 119435
Federal State Budgetary Educational Institution of Higher Education Moscow State University of Medicine and Dentistry
Moscow, 125367
Federal State Autonomous Educational Institution of Russian National Research Medical University named after. N. I. Pirogova
Moscow, 129226
Limited Liability Company "Ersi Medical"
Novosibirsk, 630005
Limited Liability Company "Medical Center "Healthy Family"
Novosibirsk, 630099
Federal State Budgetary Educational Institution of Higher Education Orenburg State Medical University of the Ministry of Health of Russia
Orenburg, 460018
Medical center, clinic "Medical Technologies"
Saint Petersburg, 191025
Limited Liability Company "Ex Seven Clinical Research"
Saint Petersburg, 194156
Limited Liability Company "Interleukin"
Saint Petersburg, 194214
Limited Liability Company "Strategic Medical Systems"
Saint Petersburg, 194291
State Budgetary Healthcare Institution Leningrad area Clinical Hospital
Saint Petersburg, 194291
JSC "North-West Center for Evidence-Based Medicine"
Saint Petersburg, 194355
Federal State Budgetary Educational Institution of Higher Education Saratov State Medical University named after. V.I.Razumovsky Ministry of Health of Russia
Saratov, 410054
Private foundation "RZD-Medicine" Smolensk"
Smolensk, 214025
State Budgetary Healthcare Institution Tula area Clinical Hospital
Tula, 300053
State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital
Ulyanovsk, 432063
State health care institution city clinical hospital №25
Volgograd, Volgograd Oblast, 400138
Limited Liability Company "CMKI-PRACTIKA"
Yaroslavl, 150003
State Budgetary Healthcare Institution "Clinical Hospital No. 2"
Yaroslavl, 150030
Central City Hospital
Yaroslavl, 150047
JSC "TsSM"
Yekaterinburg, 620043
About this study
Official title: Double-blind Multicenter Randomized Study of the Effectiveness and Safety of Tocilizumab Biosimilar (Complarate®) and Actemra® in Parallel Groups in Patients With Rheumatoid Arthritis With Repeated Intravenous Administration
This is a randomized double-blind comparative parallel group study of the efficacy and safety of tocilizumab biosimilar Complarate® and Actemra® in the treatment of patients with rheumatoid arthritis with moderate to high disease activity. Participants received an intravenous dose of tocilizumab 8 mg/kg once 4 weeks. The time on study treatment was 24 weeks.
Read the detailed description
Complarate® (INN: tocilizumab) is being developed as a biosimilar to the drug Actemra®, a concentrate for the preparation of a solution for infusion.
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 (IL-6) receptor from the immunoglobulin G1 (IgG1) subclass of immunoglobulins. Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors.
This III phase study is aimed to compare the effectiveness, safety and immunogenicity of Complarate® and Actemra®. The study included patients aged 18-75 years at the time of signing the informed consent form with a documented diagnosis of rheumatoid artritis, established according to the 2010 ACR/EULAR classification criteria, at least 6 months before screening, with moderate or high degree of disease activity and insufficient response to methotrexate monotherapy (preservation of moderate/high disease activity for at least 3 months) and/or poor tolerability of methotrexate (including the subcutaneous form of the drug) and/or insufficient response to or intolerance to other synthetic disease-modifying anti-inflammatory drugs (sDMARDs) with or without methotrexate inclusive, who meet all criteria for participation in the study. The study included a screening period and a treatment period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 2:1 to the study drug (Complarate®) and comparator drug (Actemra®). 465 patients (310 to the study drug group and 155 to the comparator drug group) were randomized.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Complarate®, Actemra®
- Keywords
- tocilizumab, humanized monoclonal antibodies, safety, rheumatoid arthritis, equivalence, biosimilar, American College of Rheumatology (ACR), DAS28, disease-modifying anti-rheumatic drugs (DMARDs), rheumatic autoimmune disease, European League Against Rheumatism (EULAR), immunogenicity, Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complarate®Biological
Also called tocilizumab biosimilar, GNR-087
The investigational drug Complarate® was administered as an intravenous infusion at a dose of 8 mg/kg once every 4 weeks for 24 weeks.
Actemra®Biological
Also called tocilizumab
The reference drug Actemra® was administered as an intravenous infusion at a dose of 8 mg/kg once every 4 weeks for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Complarate® (JSC "GENERIUM", Russia) | Experimental | tocilizumab biosimilar Receives: Biological: Complarate® |
| Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) | Active comparator | tocilizumab Receives: Biological: Actemra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with an American College of Rheumatology 20% (ACR20) response
The ACR 20 response: greater than or equal to (>/=) 20 percent (%) improvement in TJC and SJC (28 assessed joints), and 20% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at week 24
Measured: week 24
Secondary outcomes (9)
Proportion of Participants with an American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
The ACR 20, 50, and 70 responses: greater than or equal to (>/=) 20 percent (%), 50%, and 70% improvement in TJC and SJC (28 assessed joints), and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at each visit
Measured: week 24
Time to ACR20 response
The ACR 20 response: greater than or equal to (>/=) 20 percent (%) improvement in TJC and SJC (28 assessed joints), and 20% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at week 24
Measured: week 24
Change in Disease Activity Score Based on 28-Joints Count (DAS28)
DAS28 is calculated from the TJC and SJC based on a 28-joint assessment, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hour) and PtGDA assessed on 0-10 cm VAS. Higher scores indicate greater affectation due to disease activity. DAS28-ESR total score= 0-9.4. DAS28-ESR </=3.2 indicates low disease activity, DAS28-ESR >3.2 to 5.1 indicates moderate to high disease activity, and DAS28-ESR </=3.2 indicates remission.
Measured: week 24
Proportion of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 </=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1; non-responders: change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1
Measured: week 24
Area under the curve (AUC) of the disease activity index (DAS28)
DAS28 is calculated from the TJC and SJC based on a 28-joint assessment, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hour) and PtGDA assessed on 0-10 cm VAS. Higher scores indicate greater affectation due to disease activity. DAS28-ESR total score= 0-9.4. DAS28-ESR </=3.2 indicates low disease activity, DAS28-ESR >3.2 to 5.1 indicates moderate to high disease activity, and DAS28-ESR </=3.2 indicates remission.
Measured: week 24
Change in Simplified Disease Activity Index (SDAI)
SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and C-reactive protein (CRP) in milligrams per deciliter (mg/dL). Higher scores indicate greater affectation due to disease activity. SDAI total score = 0-86. SDAI </=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity
Measured: week 24
Change in Clinical Disease Activity Index (CDAI)
CDAI is a numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient's global assessment of disease activity (PtGDA) and physician global assessment of disease activity (PGDA) assessed on 0-10 centimeters (cm) visual analogue scale (VAS). Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score less than or equal to (</=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity
Measured: week 24
Proportion of Participants who achieved remission in accordance with the ACR remission criteria
Criteria for rheumatoid artritis remission (ACR/EULAR criteria, 2011). Simultaneous fulfillment of all conditions No. 1-4: 1. number of painful joints (TJ) ≤1, 2. number of swollen joints (SJ) ≤1, 3. C-reactive protein ≤1 mg/dL, 4. general assessment of the disease by the patient (OZB, according to YOUR) ≤1, OR fulfillment of condition No. 5, regardless of the fulfillment of conditions No. 1-4: 5. SDAI index ≤ 3.3.
Measured: week 24
Proportion of Participants who dropped out of the study due to insufficient treatment effectiveness
Insufficient of therapy assessed as the lack of effect after 3 months of therapy using the disease activity in rheumatoid arthritis scale (DAS28) index (from less than 2.6 scores in remission to more then 5,1 scores for very active disease)
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start13 Feb 2023
- Primary completion5 Jan 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oksana A. Markova, MD, Study chair, JSC GENERIUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475508
- Sponsor's protocol ID
- TZS-RA-III
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Multicenter Randomized Study of the Effectiveness and Safety of Tocilizumab Biosimilar (Complarate®) and Actemra® in Parallel Groups in Patients With Rheumatoid Arthritis With Repeated Intravenous Administration
- ClinicalTrials.gov ID
- NCT06475508
- Acronym / sponsor ID
- TZS-RA-III
- Conditions
- Rheumatoid Arthritis
- Keywords
- tocilizumab, humanized monoclonal antibodies, safety, rheumatoid arthritis, equivalence, biosimilar, American College of Rheumatology (ACR), DAS28
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized double-blind comparative parallel group study of the efficacy and safety of tocilizumab biosimilar Complarate® and Actemra® in the treatment of patients with rheumatoid arthritis with moderate to high disease activity. Participants received an intravenous dose of tocilizumab 8 mg/kg once 4 weeks. The time on study treatment was 24 weeks.
Detailed description
Complarate® (INN: tocilizumab) is being developed as a biosimilar to the drug Actemra®, a concentrate for the preparation of a solution for infusion.
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 (IL-6) receptor from the immunoglobulin G1 (IgG1) subclass of immunoglobulins. Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors.
This III phase study is aimed to compare the effectiveness, safety and immunogenicity of Complarate® and Actemra®. The study included patients aged 18-75 years at the time of signing the informed consent form with a documented diagnosis of rheumatoid artritis, established according to the 2010 ACR/EULAR classification criteria, at least 6 months before screening, with moderate or high degree of disease activity and insufficient response to methotrexate monotherapy (preservation of moderate/high disease activity for at least 3 months) and/or poor tolerability of methotrexate (including the subcutaneous form of the drug) and/or insufficient response to or intolerance to other synthetic disease-modifying anti-inflammatory drugs (sDMARDs) with or without methotrexate inclusive, who meet all criteria for participation in the study. The study included a screening period and a treatment period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 2:1 to the study drug (Complarate®) and comparator drug (Actemra®). 465 patients (310 to the study drug group and 155 to the comparator drug group) were randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complarate® (JSC "GENERIUM", Russia) | Experimental | Biological: Complarate®tocilizumab biosimilar |
| Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) | Active comparator | Biological: Actemra®tocilizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Availability of written informed consent obtained from the patient before the start of any procedures related to the study.
- Men and women 18-75 years of age, inclusive, at the time of signing the informed consent form.
- Patients with a documented diagnosis of rheumatoid artritis (RA), established according to the 2010 ACR/EULAR classification criteria at least 6 months before screening, with moderate to high disease activity and an insufficient response to methotrexate monotherapy (maintaining moderate/high disease activity for at least 3 months) and/or poor tolerability of methotrexate (including the subcutaneous form of the drug) and/or insufficient response to or intolerance to other synthetic disease-modifying anti-inflammatory drugs (sDMARDs) in combination with methotrexate or without methotrexate.
- The number of swollen and/or painful joints is 6 or more.
- No changes in the dosage regimen of standard RA therapy with oral glucocorticosteroids and NSAIDs for ≥ 4 weeks before screening.
Key exclusion criteria (23 listed)
- A history of rheumatic autoimmune disease other than rheumatoid arthritis.
- Functional Class IV according to the ACR Functional Status Classification or wheelchair/bedridden.
- Development of pronounced extra-articular (systemic) manifestations of the disease and complications (rheumatoid vasculitis, amyloidosis, Felty's syndrome, neuropathy, damage to the organ of vision).
- Use of oral corticosteroids in doses greater than >10 mg daily prednisolone equivalent, or change in oral corticosteroid dose within 4 weeks before or during screening.
- Use of injectable corticosteroids (including intra-articular corticosteroids) or intra-articular hyaluronic acid injections within 4 weeks before or during screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complarate®Also: tocilizumab biosimilar, GNR-087The investigational drug Complarate® was administered as an intravenous infusion at a dose of 8 mg/kg once every 4 weeks for 24 weeks. | Biological | Complarate® (JSC "GENERIUM", Russia) |
| Actemra®Also: tocilizumabThe reference drug Actemra® was administered as an intravenous infusion at a dose of 8 mg/kg once every 4 weeks for 24 weeks. | Biological | Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) |
Primary outcome
Proportion of Participants with an American College of Rheumatology 20% (ACR20) response
Time frame: week 24
The ACR 20 response: greater than or equal to (>/=) 20 percent (%) improvement in TJC and SJC (28 assessed joints), and 20% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at week 24
9 secondary outcomes
Proportion of Participants with an American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
Time frame: week 24
Time to ACR20 response
Time frame: week 24
Change in Disease Activity Score Based on 28-Joints Count (DAS28)
Time frame: week 24
Proportion of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
Time frame: week 24
Area under the curve (AUC) of the disease activity index (DAS28)
Time frame: week 24
Change in Simplified Disease Activity Index (SDAI)
Time frame: week 24
Change in Clinical Disease Activity Index (CDAI)
Time frame: week 24
Proportion of Participants who achieved remission in accordance with the ACR remission criteria
Time frame: week 24
Proportion of Participants who dropped out of the study due to insufficient treatment effectiveness
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oksana A. Markova, MD study chair
JSC GENERIUM
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Complarate® and Actemra® in people with Rheumatoid Arthritis, run by AO GENERIUM at 28 sites 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 7 inclusion and 23 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites 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. 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?
Proportion of Participants with an American College of Rheumatology 20% (ACR20) response (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.