Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Necrosis

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Adalimumab

Tumor Necrosis Factor Inhibitors

BCD-057 group includes patients with moderate to severe plaque psoriasis, who will receive BCD-057 subcutaneously at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and 23. Patients will be invited for randomization at week 24 (in order to keep the double-blind design of the study), but it will have a formal character (assignment of a new randomization number and lot). From week 25 patients of this group will continue to receive BCD-057 at a dose 40 mg on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and 51.

BCD-057 is adalimumab biosimilar, monoclonal antibody to tumor necrosis factor alfa.

Humira® group includes patients with moderate to severe plaque psoriasis, who will receive Humira® subcutaneously at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23. At week 24 participants will re-randomized (1:1) to treatment with Humira® or will transitioned to BCD-057. Patients will receive BCD-057 or Humira® at a dose 40 mg on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and 51.

BCD-057 is adalimumab biosimilar, monoclonal antibody to tumor necrosis factor alfa.

Humira® is original drug of adalimumab, monoclonal antibody to tumor necrosis factor alfa.

BCD-057 is biosimilar of adalimumab (produced by BIOCAD).

BCD-057

Humira is the original adalimumab (produced by F. Hoffman-La Roche)

Humira®

Roman Ivanov, PhD

CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy, safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD, Russia) and Humira® when used in patients with moderate to severe plaque psoriasis.

CALYPSO study is the next step of clinical evaluation of adalimumab biosimilar manufactured by joint-stock company (JSC) BIOCAD, Russia.The aim of this study is to establish that BCD-057 is equivalent to Humira® in terms of efficacy, safety and pharmacokinetics when used by the standard regimen in patients with plaque psoriasis.

The study will enroll 344 patients with moderate to severe plaque psoriasis, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-057 subcutaneously (SC) at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and 23. Then participants of this group will be invited for randomization at week 25 (in order to keep the double-blind design of the study), but it will have a formal character (assignment of a new randomization number and lot). Patients will continue to receive 40 mg of BCD-057 on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and 51.

Patients from the second group will receive Humira® subcutaneously (SC) at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and 23. At week 25 participants will re-randomized (1:1) to treatment with Humira® or will transitioned to BCD-057.They will receive Humira® or BCD-057 at a dose 40 mg on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and 51.

Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis

International Multi-center Comparative Randomized Double-blind Clinical Trial of Efficacy and Safety of BCD-057 (Adalimumab Produced by BIOCAD, Russia) and Humira® (Adalimumab Produced by Vetter Pharma-Fertigung Gmbh & Co KG, Germany) in Patients With Moderate to Severe Plaque Psoriasis

Ratio of patients who developed a decrease in Psoriasis Area Severity Index score by 75% or more (PASI75) after 16 weeks of therapy with adalimumab vs. baseline.

Percent improvement in Psoriasis Area Severity Index (PASI) after 16, 24, 33 and 55 weeks of therapy with adalimumab.

Ratio of patients who developed a decrease in Psoriasis Area Severity Index score by 75% or more (PASI75) after 33, 55 weeks of therapy with adalimumab vs. baseline.

Ratio of patients who developed a decrease in Psoriasis Area Severity Index score by 50% or more (PASI50) and Psoriasis Area Severity Index score by 90% or more (PASI90) after 16, 24, 33, 55 weeks of therapy with adalimumab vs. baseline.

Ratio of patients who have Physicians Global Assessment (sPGA) score 0 or 1 after 16, 33, 55 weeks of therapy with adalimumab.

Percent of body surface area (BSA), affected by psoriasis (measured by physician during physical examination of patient), after 16, 33, 55 weeks of therapy with adalimumab vs. baseline.

Change in Short Form-36 questionnaire (SF-36) from Week 0 to Week 16 and from Week 16 to Week 55.

Change in Dermatology Quality of Life Index questionnaire (DLQI) from Week 0 to Week 16 and from Week 16 to Week 55.

Area under the plasma concentration versus time curve (AUC) 0-tau of adalimumab after multiple adalimumab injections

Average blood concentration of adalimumab in steady state conditions (Cav,ss)

Half-life (Т½) of adalimumab after multiple adalimumab injections

Volume of distribution (Vd) of adalimumab after multiple adalimumab injections

Clearance (Cl) of adalimumab after multiple adalimumab injections

Biocad

Musculoskeletal Diseases

Immune System Diseases

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Antineoplastic Agents

Dermatologic Agents

Reproductive Control Agents

Methotrexate

Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.

Placebo matched to atacicept

Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.

Atacicept: with loading dose

Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.

Atacicept

Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.

Medical Responsible

The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.

Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)

A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=20% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).

ACR50-CRP response is defined as \>=50% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=50% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).

ACR70-CRP response is defined as \>=70% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=70% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).

The EULAR response criteria evaluate change in DAS28 scores represented as "good response", "moderate response", or "no response" considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have "good" or "moderate" EULAR response if at the time of assessment, their DAS28 score was less than or equal to (\<=) 5.1 and the improvement from baseline in their DAS28 score was greater than (\>) 0.6; or if at the time of assessment, their DAS28 score was \>5.1 and improvement from baseline in their DAS28 score was \>1.2.

An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.

Merck KGaA, Darmstadt, Germany

EMD Serono

An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.

Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.

Placebo

Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.

Atacicept 150 mg With Loading Dose

Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).

Atacicept 150 mg Without Loading Dose

Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.

Total

Age, Continuous

Sex: Female, Male

Intention-to-treat (ITT) population included all randomized participants who received at least 1 study treatment dose.

Merck KGaA Communication Center

ITT population included all randomized participants who received at least 1 study treatment dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis	NCT02762955	Psoriasis	BCD-057 Humira®	18 Years - 75 Years	Biocad
Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)	NCT00595413	Rheumatoid Arth...	Placebo matched... Atacicept: with... Atacicept Adalimumab	18 Years -	EMD Serono
Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)	NCT00595413	Rheumatoid Arth...	Placebo matched... Atacicept: with... Atacicept Adalimumab	18 Years -	EMD Serono
Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis	NCT02762955	Psoriasis	BCD-057 Humira®	18 Years - 75 Years	Biocad

Spots Global Cancer Trial Database for humira®

Every month we try and update this database with for humira® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for humira®

Every month we try and update this database with for humira® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for humira® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.