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Trial record 1 of 1 for:    NCT02359903
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Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT02359903
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Description
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Brief Summary:
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Infliximab (BCD-055) Drug: Infliximab (Remicade) Phase 1

Detailed Description:

ASART-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured by JSC BIOCAD, Russia.The aim of this study is to establish that BCD-055 is equivalent to Remicade in terms of pharmacokinetics and safety when used by the standard regimen in patients with ankylosing spondylitis (AS).

The study will enroll 90 patients with active AS, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-055 IV at a dose 5 mg/kg on week 0, 2, 6, 14 and 22; patients from the second group will receive Remicade at the same regimen.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Study Start Date : February 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: BCD-055 group
BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
 Drug: Infliximab (BCD-055)
infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
Other Names:
  • Remicade
  • BCD-055
Active Comparator: Remicade group
Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
 Drug: Infliximab (Remicade)


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade [ Time Frame: 2 weeks ]
    Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.

  2. Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade [ Time Frame: 2 weeks ]
  3. Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade [ Time Frame: 28 weeks ]
  4. Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade [ Time Frame: 28 weeks ]
  5. Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade [ Time Frame: 28 weeks ]
  6. Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade [ Time Frame: 2 weeks / 28 weeks ]
  7. Average Concentration of Infliximab at Steady State Phase [ Time Frame: 28 weeks ]
  8. Percentage of Patients in Each Group Achieving ASAS20 [ Time Frame: 14 weeks / 30 weeks ]
  9. Percentage of Patients in Each Group Achieving ASAS40 [ Time Frame: 14 weeks / 30 weeks ]
  10. Mean Change of BASDAI Score Compared With Baseline [ Time Frame: 14 weeks / 30 weeks ]
  11. Mean Change of BASMI Score Compared With Baseline [ Time Frame: 14 weeks / 30 weeks ]
  12. Mean Change of BASFI Score Compared With Baseline [ Time Frame: 14 weeks / 30 weeks ]
  13. Mean Change of MASES Score Compared With Baseline [ Time Frame: 14 weeks / 30 weeks ]
  14. Mean Change of SF36 Score Compared With Baseline [ Time Frame: 14 weeks / 30 weeks ]
  15. Mean Change of Chest Expansion Compared With Baseline [ Time Frame: 14 weeks / 30 weeks ]
  16. Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade [ Time Frame: 2 weeks ]
  17. Total Frequency of AE/SAE Within the Whole Time of the Study [ Time Frame: 30 weeks ]
  18. Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study [ Time Frame: 30 weeks ]
  19. Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected [ Time Frame: screening / 14 weeks / 30 weeks ]
  20. Frequency of Early Withdrawal Due to AE/SAE [ Time Frame: 30 weeks ]

Other Outcome Measures:
  1. Maximum Concentration at Steady State [ Time Frame: 28 weeks ]
  2. Area Under the Plasma Concentration-time Curve at Steady State Phase [ Time Frame: 28 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed informed consent
  • active ankylosing spondylitis, which exists in patient within last 3 months
  • BASDAI score > or equal to 4 points, spinal pain (by VAS) > or equal to 4 points
  • history of NSAID use for the treatment of AS within last 3 months
  • adequate renal and liver function
  • absence of severe abnormalities in complete blood count
  • consent to use adequate contraception
  • ability to follow Protocol procedures

Exclusion Criteria:

  • previously use of any biologic for AS treatment
  • total ankylosing of the spine
  • known allergy to chimeric proteins or any excipients of BCD-055/Remicade
  • hepatitis B, active hepatitis C, HIV, syphilis
  • known tuberculosis
  • latent forms of tuberculosis
  • any bacterial infection diagnosed within last month which required oral antibiotics (within last 2 weeks) or parenteral antibiotics (within last 4 weeks)
  • drug or alcohol abuse
  • any other disease which can affect assessments or masking some symptoms of AS (severe osteoarthrosis, nervous disorders with impairment of sensory or motor functions, another inflammatory joint disease apart from AS, etc.)
  • severe uncontrolled hypertension
  • chronic heart failure
  • decompensated renal or liver disorders
  • severe uncontrolled diabetes mellitus
  • chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis
  • any mental disorder, incl. severe depression or/and suicide thoughts/actions in anamnesis
  • unstable angina pectoris
  • myocardial infarction within last 12 months

Other exclusion criteria could be found in the Full Study Protocol

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359903


Locations
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Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, Belarus
Russian Federation
Chelyabinsk Regional Clinical hospital
Chelyabinsk, Russian Federation
Research Institute of Rheumotology
Moscow, Russian Federation
Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
N.Novgorod, Russian Federation
Local hospital at the station Smolensk OAO RZD
Smolensk, Russian Federation
North-Western State Medical University n.a. I.I.Mechnikov
St.Petersburg, Russian Federation
Sponsors and Collaborators
Biocad
Investigators
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Study Chair: Ivanov Roman, PhD JCS BIOCAD
More Information
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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02359903    
Other Study ID Numbers: BCD-055-1/ASART-1
First Posted: February 10, 2015    Key Record Dates
Results First Posted: June 8, 2016
Last Update Posted: June 8, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
 Arthritis
Joint Diseases
Spondylarthropathies
Ankylosis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents