BioequivalencePhase 1NCT03273192
A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects
A Phase 1 study testing Adalimumab in people with Bioequivalence and Phase 1, run by Cinnagen at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Phase 1
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIran
- Study dates
- 22 Oct 2016to 6 Aug 2017
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide signed ICF to participate in the trial and to comply with the trial procedures.
- Be healthy male and female between the ages of 18 and 45 years. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
- Have a Body Mass Index (BMI) of 19.0 to 30.5 kg/m2;
- Have Chest X ray with no evidence of current active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
- Female subjects with child-bearing potential must agree to use a medically accepted method of contraception during the trial and one month after the end of the trial. Acceptable methods of contraception include the following:
- Stable oral/transdermal/injectable hormonal contraceptive regimen without break through uterine bleeding and condom/spermicide.
Show all 9Show fewer
- Intrauterine device (inserted at least 2 months prior to screening visit) used with spermicide/condom.
- Condom (male or female) with spermicide
- Vasectomy of the male partner in conjunction with condom or spermicide.
Who cannot join
- Being doubtful about their availability to complete the trial.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic (Multiple sclerosis), autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
- Active or latent Tuberculosis or who have a history of Tuberculosis
- History of invasive systemic fungal infections or other opportunistic infections
- Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
Show all 11Show fewer
- Serious infection associated with hospitalisation and/or which required intravenous antibiotics
- History of and/or current cardiac disease
- Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the final study visit
- Intake medication with a half-life > 24 h within 4 weeks or 5 half-lives of the medication prior to investigational product administration
- Have a history of smoking >10 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
About this study
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.)
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®.
Read the detailed description
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
- Conditions
- Bioequivalence, Phase 1
- Being tested
- Adalimumab
- Keywords
- healthy subjects, adalimumab, single dose, Phase 1, PK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called CinnoRA, Humira
A single 40-mg dose of Adalimumab is administered subcutaneously to all the subjects.
| Study group | Role | What they receive |
|---|---|---|
| CinnaGen adalimumab | Experimental | 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. Receives: Drug: Adalimumab |
| AbbVie adalimumab | Active comparator | 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. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to infinity (AUCinf)
AUCinf will be calculated using the equation:AUCinf= AUClast + (Clast / Kel)
Measured: 71 days
Maximum serum concentration (Cmax)
It is obtained directly from the observed concentration-time data
Measured: 71 days
Secondary outcomes (2)
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
It is calculated using the linear trapezoidal rule
Measured: 71 days
Time to Cmax (Tmax)
It is obtained directly from the observed concentration-time data
Measured: 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start22 Oct 2016
- Primary completion6 Aug 2017
- Study completion6 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BioequivalenceStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Somayeh Amini, PharmD, Study director, Orchid Pharmed Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273192
- Sponsor's protocol ID
- ADA.CIN.AJ.95 (I-PK)
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2017
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27466231Hyland 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.
PubMed 27285856Ma 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.
PubMed 24462839Davatchi 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.
PubMed 18464299Wong 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.
PubMed 17916444Wiens 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.
PubMed 19707765Jamshidi A, Sabzvari A, Anjidani N, Shahpari R, Badri N. A randomized phase I pharmacokinetic trial comparing the potential biosimilar adalimumab (CinnoRA(R)) with the reference product (Humira(R)) in healthy volunteers. Expert Opin Investig Drugs. 2020 Mar;29(3):327-331. doi: 10.1080/13543784.2020.1723000. Epub 2020 Jan 30.
PubMed 31985294
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.)
- ClinicalTrials.gov ID
- NCT03273192
- Acronym / sponsor ID
- ADA.CIN.AJ.95 (I-PK)
- Conditions
- Bioequivalence, Phase 1
- Keywords
- healthy subjects, adalimumab, single dose, Phase 1, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2016 (actual)
- Primary completion
- 6 Aug 2017 (actual)
- Study completion
- 6 Aug 2017 (actual)
- First posted
- 6 Sep 2017 (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 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®.
Detailed description
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CinnaGen adalimumab | Experimental | Drug: AdalimumabCinnoRA® (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. |
| AbbVie adalimumab | Active comparator | Drug: AdalimumabHumira® (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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provide signed ICF to participate in the trial and to comply with the trial procedures.
- Be healthy male and female between the ages of 18 and 45 years. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
- Have a Body Mass Index (BMI) of 19.0 to 30.5 kg/m2;
- Have Chest X ray with no evidence of current active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
- Female subjects with child-bearing potential must agree to use a medically accepted method of contraception during the trial and one month after the end of the trial. Acceptable methods of contraception include the following:
Key exclusion criteria (11 listed)
- Being doubtful about their availability to complete the trial.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic (Multiple sclerosis), autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
- Active or latent Tuberculosis or who have a history of Tuberculosis
- History of invasive systemic fungal infections or other opportunistic infections
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 |
|---|---|---|
| AdalimumabAlso: CinnoRA, HumiraA single 40-mg dose of Adalimumab is administered subcutaneously to all the subjects. | Drug | AbbVie adalimumab, CinnaGen adalimumab |
Primary outcome
Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: 71 days
AUCinf will be calculated using the equation:AUCinf= AUClast + (Clast / Kel)
Maximum serum concentration (Cmax)
Time frame: 71 days
It is obtained directly from the observed concentration-time data
2 secondary outcomes
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Time frame: 71 days
Time to Cmax (Tmax)
Time frame: 71 days
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 19 Sep 2018.
- Background: PubMed 27466231Kaur 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.
- Background: PubMed 27285856Hyland 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.
- Background: PubMed 24462839Ma 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.
- Background: PubMed 18464299Davatchi 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.
- Background: PubMed 17916444Wong 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.
- Background: PubMed 19707765Wiens 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.
- Derived from this study: PubMed 31985294Jamshidi A, Sabzvari A, Anjidani N, Shahpari R, Badri N. A randomized phase I pharmacokinetic trial comparing the potential biosimilar adalimumab (CinnoRA(R)) with the reference product (Humira(R)) in healthy volunteers. Expert Opin Investig Drugs. 2020 Mar;29(3):327-331. doi: 10.1080/13543784.2020.1723000. Epub 2020 Jan 30.
- 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.
Somayeh Amini, PharmD study director
Orchid Pharmed Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adalimumab in people with Bioequivalence and Phase 1, run by Cinnagen at 1 site in Iran.
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 9 inclusion and 11 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the concentration-time curve from time zero to infinity (AUCinf) (time frame: 71 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273192, which also lists 7 linked publications.
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 19 Sep 2018.