<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03273192</url>
  </required_header>
  <id_info>
    <org_study_id>ADA.CIN.AJ.95 (I-PK)</org_study_id>
    <nct_id>NCT03273192</nct_id>
  </id_info>
  <brief_title>A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects</brief_title>
  <official_title>A Randomised, Double-blind, Single-dose, Parallel-group Study in Healthy Subjects to Demonstrate Pharmacokinetic Equivalence of CinnoRA® (Produced by CinnaGen CO.) and Humira® (the Reference Drug, Produced by AbbVie Inc.)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cinnagen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cinnagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate&#xD;
      CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and&#xD;
      tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of&#xD;
      a single dose (40 mg) of adalimumab.&#xD;
&#xD;
      The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to&#xD;
      its originator, Humira®, as assessed by the area under the serum concentration time curve&#xD;
      (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  To further compare the PK of CinnoRA® and Humira®.&#xD;
&#xD;
        -  To assess the safety of CinnoRA®.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-dose trial with one administration of each product (CinnoRA® and Humira®).&#xD;
      Each subject will participate in one treatment period, and will be randomised to receive&#xD;
      CinnoRA® or Humira® in a parallel fashion. The subjects will be closely monitored during the&#xD;
      following 24 hours (h), and will be allowed to leave the site in the next morning post&#xD;
      evaluation and blood samples will be collected prior to and at the following time points&#xD;
      after the dose: 4, 8, 12 and 24 hours post-dose (on day 2). The subjects will be requested to&#xD;
      visit the trial site on days 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29, 36, 43, 50, 57, 63 and 71&#xD;
      after dose for blood sampling and evaluation of safety variable and tolerability.&#xD;
&#xD;
      Before initiation, the trial is reviewed by food and drug administration of Iran. The&#xD;
      protocol, case report form (CRF), information for subjects and informed consent form are&#xD;
      submitted to the ethics committees responsible for review and approval purposes, according to&#xD;
      national regulatory guidelines.&#xD;
&#xD;
      In this study, no subject is recruited without an informed consent. All the informed consent&#xD;
      forms which are signed by the subjects have two copies so that subjects could receive a copy&#xD;
      of it.&#xD;
&#xD;
      This is a single-dose trial with one administration of each product (CinnoRA® and Humira®).&#xD;
      74 (group A=37, group B=37) eligible subjects have been planned to enter to the study. All of&#xD;
      whom are aged between 18 and 45 years. Subjects' randomization was done, using permuted block&#xD;
      randomization method. Both groups received 40 mg of either of the drugs as a single&#xD;
      subcutaneous injection. The injection method, injection pens and cartridges were totally the&#xD;
      same in both groups. The primary objective of this study is to demonstrate that the PK of&#xD;
      CinnoRA® is similar to its originator, Humira®, as assessed by the area under the serum&#xD;
      concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.&#xD;
      Secondary objectives include assessment of the time to Cmax (tmax), AUC from time 0 to the&#xD;
      last quantifiable concentration (AUClast) of CinnoRA® compared with Humira®, as well as&#xD;
      evaluation of safety and tolerability. The safety endpoints of the trial are to evaluate the&#xD;
      incidence of reported adverse effects, detecting changes in vital signs, clinical laboratory&#xD;
      tests (hematologic, biochemistry, urine analysis and urine culture tests) and ECG.&#xD;
&#xD;
      Determination of sample size:&#xD;
&#xD;
      An equivalence test of means AUCinf using two one-sided tests on data from a parallel-group&#xD;
      design with sample sizes of 37 in the reference group and 37 in the treatment group achieves&#xD;
      81% power at a 10% significance level when the true ratio of the means AUCinf is 1.00, the&#xD;
      coefficient of variation on the original, unlogged scale is 0.38, and the equivalence limits&#xD;
      of the mean ratio AUCinf are 0.80 and 1.25.&#xD;
&#xD;
      DATA QUALITY ASSURANCE:&#xD;
&#xD;
      CinnaGen Company conducts clinical trials according to procedures that incorporate the&#xD;
      ethical principles of GCP. Accurate and reliable data collection was assured by verification&#xD;
      and cross-check of the CRFs against the subject's records by clinical monitors (source&#xD;
      document verification was performed), and the maintenance of a drug-dispensing log by the&#xD;
      center. A comprehensive validation check program was used to verify the data, and discrepancy&#xD;
      reports were generated accordingly for resolution by the investigator.&#xD;
&#xD;
      Blinding:&#xD;
&#xD;
      This is a double-blind trial. During the clinical phase of the trial, neither the subjects&#xD;
      nor the site personnel are aware of the identity (CinnoRA® and Humira®) of the treatments&#xD;
      administered. However, there is an unblinded person who receives the randomisation list and&#xD;
      dispenses the trial drugs according to the list. The unblinded person is not otherwise&#xD;
      participate in the execution of the trial. The randomisation list determines the dispensing&#xD;
      order of the trial products for each subject and only the randomisation number appear on the&#xD;
      sample collection logs, as well as, on the sample aliquots delivered to the bioanalytical&#xD;
      laboratory. Thus, the personnel responsible for analysing the PK samples are also be blinded.&#xD;
&#xD;
      Randomisation envelopes are stored in the ISF, in a locked cabinet. In a case of emergency,&#xD;
      the code of an individual subject may be opened and the reasons for opening will be&#xD;
      documented and the subject will be discontinued from the trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2016</start_date>
  <completion_date type="Actual">August 6, 2017</completion_date>
  <primary_completion_date type="Actual">August 6, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve from time zero to infinity (AUCinf)</measure>
    <time_frame>71 days</time_frame>
    <description>AUCinf will be calculated using the equation:AUCinf= AUClast + (Clast / Kel)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum serum concentration (Cmax)</measure>
    <time_frame>71 days</time_frame>
    <description>It is obtained directly from the observed concentration-time data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)</measure>
    <time_frame>71 days</time_frame>
    <description>It is calculated using the linear trapezoidal rule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cmax (Tmax)</measure>
    <time_frame>71 days</time_frame>
    <description>It is obtained directly from the observed concentration-time data</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Bioequivalence</condition>
  <condition>Phase 1</condition>
  <arm_group>
    <arm_group_label>CinnaGen adalimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CinnoRA® (adalimumab auto-injector devices produced by CinnaGen Company) 40 mg/0.8 ml in auto-injector devices A single 40-mg dose of Adalimumab was subcutaneously administered to healthy subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AbbVie adalimumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Humira® (adalimumab auto-injector devices produced by AbbVie Company) 40 mg/0.8 ml in auto-injector devices A single 40-mg dose of Adalimumab was subcutaneously administered to healthy subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>A single 40-mg dose of Adalimumab is administered subcutaneously to all the subjects.</description>
    <arm_group_label>AbbVie adalimumab</arm_group_label>
    <arm_group_label>CinnaGen adalimumab</arm_group_label>
    <other_name>CinnoRA</other_name>
    <other_name>Humira</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provide signed ICF to participate in the trial and to comply with the trial&#xD;
             procedures.&#xD;
&#xD;
          2. Be healthy male and female between the ages of 18 and 45 years. Healthy is defined as&#xD;
             no clinically relevant abnormalities identified by a detailed medical history,&#xD;
             complete physical examination including blood pressure and heart rate measurement, 12&#xD;
             lead ECG and clinical laboratory tests.&#xD;
&#xD;
          3. Have a Body Mass Index (BMI) of 19.0 to 30.5 kg/m2;&#xD;
&#xD;
          4. Have Chest X ray with no evidence of current active TB or previous (inactive) TB,&#xD;
             general infections, heart failure, malignancy, or other clinically significant&#xD;
             abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a&#xD;
             qualified radiologist.&#xD;
&#xD;
          5. Female subjects with child-bearing potential must agree to use a medically accepted&#xD;
             method of contraception during the trial and one month after the end of the trial.&#xD;
             Acceptable methods of contraception include the following:&#xD;
&#xD;
               -  Stable oral/transdermal/injectable hormonal contraceptive regimen without break&#xD;
                  through uterine bleeding and condom/spermicide.&#xD;
&#xD;
               -  Intrauterine device (inserted at least 2 months prior to screening visit) used&#xD;
                  with spermicide/condom.&#xD;
&#xD;
               -  Condom (male or female) with spermicide&#xD;
&#xD;
               -  Vasectomy of the male partner in conjunction with condom or spermicide.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Being doubtful about their availability to complete the trial.&#xD;
&#xD;
          2. Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic&#xD;
             (Multiple sclerosis), autoimmune, or allergic disease (including drug allergies, but&#xD;
             excluding untreated, asymptomatic, seasonal allergies at the time of dosing).&#xD;
&#xD;
          3. Previous history of cancer, except for adequately treated basal cell or squamous cell&#xD;
             carcinoma of the skin.&#xD;
&#xD;
          4. Active or latent Tuberculosis or who have a history of Tuberculosis&#xD;
&#xD;
          5. History of invasive systemic fungal infections or other opportunistic infections&#xD;
&#xD;
          6. Systemic or local infection, a known risk for developing sepsis and/or known active&#xD;
             inflammatory process&#xD;
&#xD;
          7. Serious infection associated with hospitalisation and/or which required intravenous&#xD;
             antibiotics&#xD;
&#xD;
          8. History of and/or current cardiac disease&#xD;
&#xD;
          9. Have received live vaccine(s) within 4 weeks prior to Screening or who will require&#xD;
             live vaccine(s) between Screening and the final study visit&#xD;
&#xD;
         10. Intake medication with a half-life &gt; 24 h within 4 weeks or 5 half-lives of the&#xD;
             medication prior to investigational product administration&#xD;
&#xD;
         11. Have a history of smoking &gt;10 cigarettes per day.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Somayeh Amini, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>Orchid Pharmed Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orchidpharmed PK/PD site</name>
      <address>
        <city>Tehran</city>
        <zip>1425614985</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <reference>
    <citation>Kaur P, Chow V, Zhang N, Moxness M, Kaliyaperumal A, Markus R. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis. 2017 Mar;76(3):526-533. doi: 10.1136/annrheumdis-2015-208914. Epub 2016 Jul 27.</citation>
    <PMID>27466231</PMID>
  </reference>
  <reference>
    <citation>Hyland E, Mant T, Vlachos P, Attkins N, Ullmann M, Roy S, Wagner V. Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira((R)) in healthy subjects. Br J Clin Pharmacol. 2016 Oct;82(4):983-93. doi: 10.1111/bcp.13039. Epub 2016 Jul 28.</citation>
    <PMID>27285856</PMID>
  </reference>
  <reference>
    <citation>Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1. doi: 10.1016/j.apmr.2013.10.032. Epub 2014 Jan 21.</citation>
    <PMID>24462839</PMID>
  </reference>
  <reference>
    <citation>Davatchi F, Jamshidi AR, Banihashemi AT, Gholami J, Forouzanfar MH, Akhlaghi M, Barghamdi M, Noorolahzadeh E, Khabazi AR, Salesi M, Salari AH, Karimifar M, Essalat-Manesh K, Hajialiloo M, Soroosh M, Farzad F, Moussavi HR, Samadi F, Ghaznavi K, Asgharifard H, Zangiabadi AH, Shahram F, Nadji A, Akbarian M, Gharibdoost F. WHO-ILAR COPCORD Study (Stage 1, Urban Study) in Iran. J Rheumatol. 2008 Jul;35(7):1384. Epub 2008 May 1.</citation>
    <PMID>18464299</PMID>
  </reference>
  <reference>
    <citation>Wong M, Ziring D, Korin Y, Desai S, Kim S, Lin J, Gjertson D, Braun J, Reed E, Singh RR. TNFalpha blockade in human diseases: mechanisms and future directions. Clin Immunol. 2008 Feb;126(2):121-36. doi: 10.1016/j.clim.2007.08.013. Epub 2007 Oct 3.</citation>
    <PMID>17916444</PMID>
  </reference>
  <reference>
    <citation>Wiens A, Correr CJ, Venson R, Otuki MF, Pontarolo R. A systematic review and meta-analysis of the efficacy and safety of adalimumab for treating rheumatoid arthritis. Rheumatol Int. 2010 Jun;30(8):1063-70. doi: 10.1007/s00296-009-1111-4. Epub 2009 Aug 26.</citation>
    <PMID>19707765</PMID>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>healthy subjects</keyword>
  <keyword>adalimumab</keyword>
  <keyword>single dose</keyword>
  <keyword>Phase 1</keyword>
  <keyword>PK</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03273192
org study id: ADA.CIN.AJ.95 (I-PK)
nct id: NCT03273192
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate
      CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and
      tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of
      a single dose (40 mg) of adalimumab.

      The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to
      its originator, Humira®, as assessed by the area under the serum concentration time curve
      (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.

      The secondary objectives of the study are:

        -  To further compare the PK of CinnoRA® and Humira®.

        -  To assess the safety of CinnoRA®.
This is a single-dose trial with one administration of each product (CinnoRA® and Humira®).
      Each subject will participate in one treatment period, and will be randomised to receive
      CinnoRA® or Humira® in a parallel fashion. The subjects will be closely monitored during the
      following 24 hours (h), and will be allowed to leave the site in the next morning post
      evaluation and blood samples will be collected prior to and at the following time points
      after the dose: 4, 8, 12 and 24 hours post-dose (on day 2). The subjects will be requested to
      visit the trial site on days 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29, 36, 43, 50, 57, 63 and 71
      after dose for blood sampling and evaluation of safety variable and tolerability.

      Before initiation, the trial is reviewed by food and drug administration of Iran. The
      protocol, case report form (CRF), information for subjects and informed consent form are
      submitted to the ethics committees responsible for review and approval purposes, according to
      national regulatory guidelines.

      In this study, no subject is recruited without an informed consent. All the informed consent
      forms which are signed by the subjects have two copies so that subjects could receive a copy
      of it.

      This is a single-dose trial with one administration of each product (CinnoRA® and Humira®).
      74 (group A=37, group B=37) eligible subjects have been planned to enter to the study. All of
      whom are aged between 18 and 45 years. Subjects' randomization was done, using permuted block
      randomization method. Both groups received 40 mg of either of the drugs as a single
      subcutaneous injection. The injection method, injection pens and cartridges were totally the
      same in both groups. The primary objective of this study is to demonstrate that the PK of
      CinnoRA® is similar to its originator, Humira®, as assessed by the area under the serum
      concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.
      Secondary objectives include assessment of the time to Cmax (tmax), AUC from time 0 to the
      last quantifiable concentration (AUClast) of CinnoRA® compared with Humira®, as well as
      evaluation of safety and tolerability. The safety endpoints of the trial are to evaluate the
      incidence of reported adverse effects, detecting changes in vital signs, clinical laboratory
      tests (hematologic, biochemistry, urine analysis and urine culture tests) and ECG.

      Determination of sample size:

      An equivalence test of means AUCinf using two one-sided tests on data from a parallel-group
      design with sample sizes of 37 in the reference group and 37 in the treatment group achieves
      81% power at a 10% significance level when the true ratio of the means AUCinf is 1.00, the
      coefficient of variation on the original, unlogged scale is 0.38, and the equivalence limits
      of the mean ratio AUCinf are 0.80 and 1.25.

      DATA QUALITY ASSURANCE:

      CinnaGen Company conducts clinical trials according to procedures that incorporate the
      ethical principles of GCP. Accurate and reliable data collection was assured by verification
      and cross-check of the CRFs against the subject's records by clinical monitors (source
      document verification was performed), and the maintenance of a drug-dispensing log by the
      center. A comprehensive validation check program was used to verify the data, and discrepancy
      reports were generated accordingly for resolution by the investigator.

      Blinding:

      This is a double-blind trial. During the clinical phase of the trial, neither the subjects
      nor the site personnel are aware of the identity (CinnoRA® and Humira®) of the treatments
      administered. However, there is an unblinded person who receives the randomisation list and
      dispenses the trial drugs according to the list. The unblinded person is not otherwise
      participate in the execution of the trial. The randomisation list determines the dispensing
      order of the trial products for each subject and only the randomisation number appear on the
      sample collection logs, as well as, on the sample aliquots delivered to the bioanalytical
      laboratory. Thus, the personnel responsible for analysing the PK samples are also be blinded.

      Randomisation envelopes are stored in the ISF, in a locked cabinet. In a case of emergency,
      the code of an individual subject may be opened and the reasons for opening will be
      documented and the subject will be discontinued from the trial
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Area under the concentration-time curve from time zero to infinity (AUCinf)
time frame: 71 days
description: AUCinf will be calculated using the equation:AUCinf= AUClast + (Clast / Kel)
measure: Maximum serum concentration (Cmax)
time frame: 71 days
description: It is obtained directly from the observed concentration-time data
measure: Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
time frame: 71 days
description: It is calculated using the linear trapezoidal rule
measure: Time to Cmax (Tmax)
time frame: 71 days
description: It is obtained directly from the observed concentration-time data
arm group label: CinnaGen adalimumab
arm group type: Experimental
description: CinnoRA® (adalimumab auto-injector devices produced by CinnaGen Company) 40 mg/0.8 ml in auto-injector devices A single 40-mg dose of Adalimumab was subcutaneously administered to healthy subjects.
arm group label: AbbVie adalimumab
arm group type: Active Comparator
description: Humira® (adalimumab auto-injector devices produced by AbbVie Company) 40 mg/0.8 ml in auto-injector devices A single 40-mg dose of Adalimumab was subcutaneously administered to healthy subjects.
intervention type: Drug
intervention name: Adalimumab
description: A single 40-mg dose of Adalimumab is administered subcutaneously to all the subjects.
arm group label: AbbVie adalimumab
arm group label: CinnaGen adalimumab
other name: CinnoRA
other name: Humira
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Somayeh Amini, PharmD
role: Study Director
affiliation: Orchid Pharmed Company
facility: 
country: Iran, Islamic Republic of
citation: Kaur P, Chow V, Zhang N, Moxness M, Kaliyaperumal A, Markus R. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis. 2017 Mar;76(3):526-533. doi: 10.1136/annrheumdis-2015-208914. Epub 2016 Jul 27.
PMID: 27466231
citation: Hyland E, Mant T, Vlachos P, Attkins N, Ullmann M, Roy S, Wagner V. Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira((R)) in healthy subjects. Br J Clin Pharmacol. 2016 Oct;82(4):983-93. doi: 10.1111/bcp.13039. Epub 2016 Jul 28.
PMID: 27285856
citation: Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1. doi: 10.1016/j.apmr.2013.10.032. Epub 2014 Jan 21.
PMID: 24462839
citation: Davatchi F, Jamshidi AR, Banihashemi AT, Gholami J, Forouzanfar MH, Akhlaghi M, Barghamdi M, Noorolahzadeh E, Khabazi AR, Salesi M, Salari AH, Karimifar M, Essalat-Manesh K, Hajialiloo M, Soroosh M, Farzad F, Moussavi HR, Samadi F, Ghaznavi K, Asgharifard H, Zangiabadi AH, Shahram F, Nadji A, Akbarian M, Gharibdoost F. WHO-ILAR COPCORD Study (Stage 1, Urban Study) in Iran. J Rheumatol. 2008 Jul;35(7):1384. Epub 2008 May 1.
PMID: 18464299
citation: Wong M, Ziring D, Korin Y, Desai S, Kim S, Lin J, Gjertson D, Braun J, Reed E, Singh RR. TNFalpha blockade in human diseases: mechanisms and future directions. Clin Immunol. 2008 Feb;126(2):121-36. doi: 10.1016/j.clim.2007.08.013. Epub 2007 Oct 3.
PMID: 17916444
citation: Wiens A, Correr CJ, Venson R, Otuki MF, Pontarolo R. A systematic review and meta-analysis of the efficacy and safety of adalimumab for treating rheumatoid arthritis. Rheumatol Int. 2010 Jun;30(8):1063-70. doi: 10.1007/s00296-009-1111-4. Epub 2009 Aug 26.
PMID: 19707765
responsible party type: Sponsor
mesh term: Adalimumab
sharing ipd: No