A Randomized, Double-blind Controlled Study to Determine the Effectiveness, Safety and Tolerability of Actorif® Compared to Rebif® in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS)
The Trial is performed in a research center on 2 groups of 72 patients with RRMS who will be chosen based on inclusion and exclusion criteria and randomization that will allocate two different types of INF-β-1a, Actorif and Rebif to our patients. The occurrence of side effects, Tolerability and clinical efficiency will be assessed by evaluating patients on definite times during treatment which takes 12 month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030512398N3
Registration date:2014-03-04, 1392/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-04, 1392/12/13
Registrant information
Name
Farhad Hatami Sadabadi
Name of organization / entity
Actover Pharmaceutical Company
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 1704
Email address
farhad.hatami@actoverco.com
Recruitment status
Recruitment complete
Funding source
Biosun Pharmed Pharmaceutical Company
Expected recruitment start date
2011-10-21, 1390/07/29
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized, Double-blind Controlled Study to Determine the Effectiveness, Safety and Tolerability of Actorif® Compared to Rebif® in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS)
Public title
The Effectiveness, Safety and Tolerability of Actorif® Compared to Rebif® in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Male or female patients aged between 18-55 years, with a diagnosis of RRMS based on McDonald criteria 2010and or have two relapses in previous two years, and are eligible for interferon beta 1a therapy according to indications and clinical use in the product monograph; Patients must have an EDSS score of 0.0 to 5.5;Patients must have at least 2 relapses in previous 2 years; Signed informed consent obtained prior to initiation the study; Patients do not have any condition that mandates excluding them from the study; Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the Investigator for four weeks prior to the study and during the study. For the purposes of this study, child-bearing potential is defined as: “All female patients unless they are post-menopausal for at least one year or are surgically sterile”; Ability to co-operate with the treatment and follow up.
Exclusion Criteria
Disease-dependent criteria(Participant has an ongoing MS relapse; Has any progressive form of MS;Presenting MS relapse within 30 days prior to study drug administration); Safety of treatment dependent criteria: Presence of any serious concomitant systemic disorders incompatible with the administration of interferon beta-1a or any systemic disease that can influence the patient's safety(history of hypersensitivity to natural or recombinant interferon beta-1a, or hypersensitivity to human albumin or any other component of the formulation; History of uncontrolled seizures within the 3 months prior to enrollment; History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment; Serious local infection or systemic infection within 8 weeks prior to enrollment; Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception; History of major depression; History of major cardiac disease; History of known malignancy(except: S.C.C,B.C.C, non melanoma) or patient who is under chemotherapy); Patients with inadequate organ function(Bone Marrow: absolute neutrophil count (ANC) ≤ 1.5 x 109/L, platelet count ≤100 x 109/L,Hemoglobin ≤ 9 g/dL; Hepatic: Bilirubin ≥ 1.5 x the upper limit of normal (ULN),aspartate transaminases (AST/SGOT) And/or alkaline transaminases(ALT/SGPT)≥2.5xULN,alkaline phosphatase (AP)≥2.5 x ULN; Renal: Serum creatinine ≥1.5 mg/dL or creatinine clearance ≤ 60 mL/min calculated according to the Cockroft and Gault formula); Criteria dependent on compliance with study procedures, or the evaluation of the disability(Unwilling to use a reliable and acceptable contraceptive method throughout the study period;Conditions interfering with Magnetic Resonance Imaging (MRI) or Gadolinium DTPA (Gadovist, contrast agent) allergy or Inability to undergo MRI with gadolinium administration;Treatment with certain other agents to treat MS underlying disease; Participant received any other approved disease modifying therapy for MS (e.g. glatiramer acetate IV, Immunoglobulin, Azathriopine, Methotrexate, Cyclophosphamide, Mitoxantrona, Plasmapheresis) or any cytokine or anti-cytokine therapy within the 3 months prior to Study Day 0 (SD0);Systemic corticosteroids within 30 days prior to the initiation of this study treatment;Treatment with any investigational product within 30 days prior to study drug administration; Previous participation in this study.)
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor of Shahed Medical University,Neurology department
Street address
Shahed University,apposite of the Emam Khomeini Shrine,Tehran-Ghom free way,Tehran,Iran
City
Tehran
Postal code
3319118651
Approval date
2013-03-06, 1391/12/16
Ethics committee reference number
41.166347
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Safety outcome :Prevalence of Flu like Syndrome
Timepoint
At 6th,12th months after initial treatmen
Method of measurement
The Frequency of Flu like syndrom
2
Description
Effectiveness outcome: The proportion of Relapse
Timepoint
At 6th,12th months after initial treatment
Method of measurement
The frequency of relapse (Clinical,MRI)
3
Description
Tolerability outcome: The prevalence of Heacache
Timepoint
At 6th,12th months after initial treatment
Method of measurement
The Frequency of headache
Secondary outcomes
1
Description
Effectiveness outcome: Proportion of progression
Timepoint
At 3th, 6th,12th months after initial treatment
Method of measurement
The frequency of progression(Clinical,EDSS, MRI)
2
Description
Safety outcome: Prevalence of Injection site reaction
Timepoint
At 6th,12th months after initial treatment
Method of measurement
The frequency of injection site reaction
3
Description
Safety outcome: Prevalence of Laboratory abnormalities
Timepoint
At 6th,12th months after initial treatment
Method of measurement
The frequency laboratory abnormalities( LFT,leukopenia)
4
Description
Tolerability outcome: The prevalence of AEs
Timepoint
At 6th,12th months after initial treatment
Method of measurement
The frequency of AEs(Vomiting,Nausea)
Intervention groups
1
Description
Group A (Intervention): They get Actorif (Interferon beta-1a) 44mcg/0.5ml in prefilled syringes, Supplied by Actover/Amegabiotech. It will be administered 3 times a week subcutaneously.
Category
Treatment - Drugs
2
Description
Group B (Control) : They get Rebif (Interferon beta-1a) beta -1a 44mcg/0.5ml in prefilled syringes, Supplied by Merck Serono .It will be administered 3 times a week subcutaneously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kheradmand Research Center
Full name of responsible person
Dr Ali Etemadrezaei
Street address
Unit 15,No.47,South Kheradmand Ave, Karim khan Zand St,Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Biosun Pharmed Company
Full name of responsible person
Shima Kheibari
Street address
Unit 702, No.14, Golestan Alley, Aghaalikhani St., Sheikh Bahaei Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Biosun Pharmed Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Actover Pharmaceutical Company
Full name of responsible person
Farhad Hatami Sadabadi (MD)
Position
Monitor / MD
Other areas of specialty/work
Street address
No.17, Dashte Behesht Ave,Saadat abad Ave,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 2206 9696
Fax
Email
Farhad.hatami@actoverco.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University,Medical University,Nourolgy department
Full name of responsible person
Seyed Massood Nabavi (MD)
Position
Principal Investigator ,Nourologist / Associate professor
Other areas of specialty/work
Street address
Mostafa Khomeini Hospital, Italia St.,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8800 3134
Fax
Email
Massoodnabavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Actover Pharmaceutical Company
Full name of responsible person
Farhad Hatami Sadabadi (MD)
Position
Monitor / MD
Other areas of specialty/work
Street address
No.17, Dashte Behesht Ave,Saadat abad Ave.
City
Tehran
Postal code
Phone
+98 21 2206 9696
Fax
Email
farhad.hatami@actoverco.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)