Rheumatoid ArthritisPhase 1NCT04885829
Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers
A Phase 1 study testing Tocilizumab Prefilled Syringe in people with Rheumatoid Arthritis and Giant Cell Arteritis, run by Syneos Health at 4 sites in 3 countries.
Trial summary
A single dose, two period trial where participants will be given either of 3 Tocilizumab product on Day 1 during period 1 and either one of the remaining 2 Tocilizumab products on Day 1 period 2. There will be at least 6 weeks (42 days) of wash out between subsequent two period dosing. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Giant Cell Arteritis
- What is being tested?
- Tocilizumab Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 31 May 2021to 4 May 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers, 18 to 50 years of age at the time of signing informed consent.
- In general good health as determined by a qualified physician based on a comprehensive medical history, physical examination including vital signs, laboratory haematology, clinical chemistry, urinalysis and 12-lead ECG during screening.
- BMI between 18.5 - 30.0 kg/m2 and body weight between 50 and 100 kg (both inclusive).
- Screening parameters (vital signs, physical examination, clinical laboratory tests, 12-lead ECG, chest X-ray, thyroid function etc.) are within the normal range or if outside the normal range, assessed as clinically non-significant by the Investigator (unless the value constitutes an explicit exclusion criterion).
- Male volunteers must be willing to abstain from sexual intercourse, sperm donation or willing to use in all relationships with a partner from the opposite sex a condom for the male partner and another effective method of contraception (such as an intra-uterine device, vaginal ring, oral contraceptive, injectable progesterone, or sub-dermal implant) for the female partner from the time of dosing until 3 months after the last dosing date, unless one of the partners is medically confirmed to be either infertile or surgically sterile.
- Female volunteers should be either post-menopausal or surgically sterile. Note: ("Postmenopausal" is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy)
- Capable, and amenable, to provide written informed consent to the study requirements.
- Willing to abide by study restrictions for the entire study duration.
Who cannot join
- Positive test result for Quantiferon-TB Gold test, syphilis, hepatitis B, hepatitis C, or HIV-1 or 2.
- Any prior exposure to tocilizumab or to any other agent directly acting on interleukin-6 or on its receptors including investigational products (e.g. siltuximab, sarilumab etc.).
- Live virus vaccination within 3 months prior to screening or intention to receive live virus vaccination during the trial or up to 3 months after the administration of the study drug.
- Administration of immunoglobulins for anti-tetanus and antirabies post-exposure prophylaxis within 3 weeks prior to administration of study drug.
- History of immunodeficiency or other clinically significant immunological disorders, or auto-immune disorders, ongoing or frequent/ recurring infection defined as more than 3 per year requiring treatment or prior herpes zoster not fully healed (including the post-herpetic neuralgia period if occurring) within one year prior to randomization or history of systemic fungal infection at any time.
- Allergy, or hypersensitivity to any recombinant human, or humanized antibodies, other therapeutic proteins, or any excipients in the study formulations.
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- Current manifestation of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma including childhood asthma currently showing clinical manifestations, urticaria, angioedema, eczematous dermatitis), hypersensitivity, or allergic reactions.
- Non-suitable skin for dosing or post-dosing evaluations of upper arm (same arm to be used as the injection site in the both periods) for any reasons (including presence of tattoos, skin pigmentation disorders, scarring etc., which may obscure the injection site).
- Blood donation, participation in any study requiring repeated blood sampling or haemorrhage requiring treatment or any transfusion in the past 3 months.
- Screening blood pressure higher than 140 mm Hg (systolic) or higher than 90 mm Hg (diastolic) or volunteers currently on anti-hypertensive drugs. Up to two repeats on different days are allowed and, in this case, the mean of the measurements will be used to decide on eligibility. Screening blood pressure is to be measured in the sitting position after 5 minutes rest.
- History of relevant orthostatic hypotension, fainting spells, or blackouts deemed in the opinion of the Investigator to pose clinical risk to the subjects.
- QTc (Fridericia correction) longer than 450 milliseconds or other clinically relevant ECG abnormalities such as atrial fibrillation, atrial flutter, Wolf-Parkinson-White syndrome, or presence of a cardiac pacemaker.
- History or presence of any clinically relevant nervous system disease including, but not restricted to any stroke/TIA (Transient Ischemic Attack), or of seizures other than febrile seizures before the age of 5 years.
- History of and/or current gastrointestinal, renal endocrine, pulmonary, hepatic, cardiovascular (including history of or presence of angina, exertional dyspnoea, orthopnoea, congestive heart failure or myocardial infarction and thrombotic or embolic episode requiring treatment), hematological (including pancytopenia, aplastic anemia or blood dyscrasia and coagulopathies, or an INR higher than 1.5), metabolic (including known diabetes mellitus) considered as significant by the Investigator. This criterion includes any disorder or condition that, in the Investigator's opinion, may interfere with the safety of the subject, the study evaluations or the subject compliance to the study procedures and limitations.
- ALT or AST higher than 1.25 times the ULN at screening.
- Neutrophil count below 2 x 109/liter (2,000 per mm3) or platelet count below 100 x 109/liter (100,000 per mm3) at screening.
- Clinically relevant hyperlipidemia (fasting serum LDL-cholesterol higher than 190 mg/dL or fasting serum triglycerides higher than 200 mg/dL or subject currently on antihyperlipidemic drugs).
- Any active infection, even if minor, ongoing at the time of screening or dosing.
- Presence of any non-healed wound or bone fracture of a clinically relevant size (in the Investigator's opinion).
- Participation in an interventional or Phase I study in the last three months, or on, or participation in more than 3 studies of experimental drug products in the past 12 months, or intake of an investigational drug in another trial within 3 months or 5 half-lives (whichever is longer) prior to intake of study drug in this trial or planned intake of an investigational drug (any drug administered in a clinical trial setting is considered an investigational drug) or follow up visit scheduled from any study during the course of this trial or intake for any reason in the last 6 months of some specific long body residence drugs such as any immunoglobulin or antibody drug (except for post-exposure prophylaxis of tetanus or rabies given more than 3 weeks before the date of the first study drug dose) pirimethamine, teicoplanin, systemic retinoids, mefloquine and hydroxychloroquine.
- History of any cancer, including carcinoma in situ, lymphoma or leukemia.
- History of, or current intestinal ulceration or diverticulitis.
- Major surgery within the past 12 months, major surgery planned within 12 months of study enrolment or any surgery including dental interventions planned within 3 months of study enrolment.
- Intake of any medication including herbal products within 3 weeks prior to dosing other than for the exceptions detailed in Section 10.2-Prior and Concomitant Medications.
- Current smokers or those who gave up smoking less than 3 months prior to screening, (thus 3 months cessation required at screening time), including alternative tobacco products such as chewing tobacco and vaping, or positive urine cotinine test at screening.
- Positive test for alcohol in breath or drugs of abuse (including benzodiazepines, amphetamines, barbiturates, cocaine, methadone, phencyclidine 3,4-methylenedioxymethamphetamine [MDMA/ecstasy], tetrahydrocannabinol, and opiates) in urine.
- Any history of difficulty in blood sampling or any vasovagal attack during blood sampling which in the opinion of the Investigator may relevantly interfere with the study sampling.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
New Zealand2 sites
Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited)
Christchurch, 8011
Auckland Clinical Studies Ltd (NZCR OpCo Limited)
Grafton, Auckland, 1010
About this study
Official title: A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers
A single dose, two period trial where participants will be given either of 3 Tocilizumab product on Day 1 during period 1 and either one of the remaining 2 Tocilizumab products on Day 1 period 2. There will be at least 6 weeks (42 days) of wash out between subsequent two period dosing. The maximum flexibility allowed between subsequent periods will be up to 9 weeks (63 days).
Names of the 3 tocilizumab products are DRL_TC, RP and RMP. So if a participant receives DRL_TC on Day 1 Period 1 then he/she will either receive RP/RMP on Day 1 Period 2.
Read the detailed description
The study will be conducted at 4 sites (2 in New Zealand, 1 in Australia and 1 in India) The three pairwise product comparisons (DRL_TC vs. RP; DRL_TC vs RMP and RP vs. RMP)will be performed in parallel. Each comparison will be separately considered. Study subjectswill be randomly assigned in a 1:1:1 ratio to one of the comparisons and within eachcomparison subjects will be randomized in a 1:1 ratio to one of the two possible productsequences The total duration of the individual subject study participation will be at least 12weeks. Dosing for period 1 will be on on day 1 followed by washout out period of upto 9weeks. Dosing for Period 2 will be on Day 1.
Subjects who complete the study and are found to be positive for anti-drug antibodies (ADA)on Day 29 and/or Day 43 period 2, will be followed up every 90 days for immunogenicitysampling up to approximately one year post Period II dosing, or until two consecutive sampleshave been negative for ADA, whichever is earlier. Early dropouts will be tested forimmunogenicity at the time of EOS and if they are positive for ADAs they will be followed-up ifpossible at 90 days intervals starting from the last received dose (either Period I or Period II) ina similar manner.
300 NHV (Normal Healthy Volunteers) will be included in the study as justified under samplesize justification. After the data of these 300 volunteers become available a blinded samplesize re-estimation (BSSR) will be performed to reconfirm the statistical assumptions of thestudy design and depending upon the outcome of the BSSR, study may be stopped or thesample size may be increased, as needed to attain the required statistical power.
- Conditions
- Rheumatoid Arthritis, Giant Cell Arteritis
- Being tested
- Tocilizumab Prefilled Syringe
- Medical subject headings
- Arthritis, Rheumatoid, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab Prefilled SyringeDrug
Also called Actemra, RoActemra
0.9ml Subcutaneous pre-filled syringes containing 162mg of Tocilizumab.
| Study group | Role | What they receive |
|---|---|---|
| DRL_TC | Experimental | Subcutaneous injection of DRL's Tocilizumab Receives: Drug: Tocilizumab Prefilled Syringe |
| RP and RMP | Active comparator | Subcutaneous injection of Actemra and RoActemra (Commercially available Tocilizumab) Receives: Drug: Tocilizumab Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP and RP vs RMP.
AUC0-∞ and AUC0-t will be calculated
Measured: Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days)
To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP
Cmax will be calculated
Measured: Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days)
Secondary outcomes (18)
Safety assessment
Abnormal blood pressure
Measured: Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
Safety assessment
Abnormal pulse rate
Measured: Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
Safety assessment
Abnormal respiratory rate
Measured: Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
Safety assessment
Abnormal aural temperature
Measured: Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
Safety assessment
Assessment of outcome of Adverse events
Measured: Screening (Day -28 to -2) to EOS visit
Safety assessment
Injection site reaction inspection (FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials to be used)
Measured: 2,24,36,48,60,72 and 84 hours post dosing.
Safety assessment
Normal 12 Lead ECG
Measured: Period I - Screening (Days -28 to -2), Day -1 (check- in), 1 (dosing),4, 5 and Period II - Day 1 (check- in), 1 (dosing) 4, 5 , 43 (-2 to +4 days)
Safety assessment
Abnormal Clinical laboratory data ((Total blood count including hemoglobin, hematocrit, mean corpuscular volume, leukocyte counts (total and differential), and platelet count)
Measured: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Abnormal Clinical lab tests (Urea, creatinine, uric acid, glucose, ALT, AST, total bilirubin (and direct if increased), sodium, potassium, chloride, calcium, total proteins, albumin, and LDH)
Measured: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Abnormal Clinical lab tests (Coagulation test (aPTT (Activated partial thromboplastin time) and INR (International Normalized Ratio))
Measured: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Abnormal Clinical lab tests (Thyroid hormones (T3, T4 and TSH))
Measured: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Abnormal Clinical lab tests (Lipid profile (including total, LDL and HDL Cholesterol as well as trigycerides)
Measured: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Abnormal Clinical lab tests (Urine evaluation with dipstick (confirmation with microscopic examination, if abnormalities are found))
Measured: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - check-in (day -1), 2, 5, 9, 15, 29 ,43 (-2 to +4 days)
IL-6 assessment
Change from pre-dose to selected time-points post-dose
Measured: Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
hsCRP assessment
Change from pre-dose to selected time-points post-dose
Measured: Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
Neutrophil assessment
Change from pre-dose to selected time-points post-dose
Measured: Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
Lipid parameters assessment
Change from baseline to selected time-points post-dose (Total, LDL, HDL and trigylcerides)
Measured: Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
Immunogenicity assessment
Presence of anti-drug antibodies (Confirmed positive samples, will be further tested for titre and presence of neutralizing antibodies (NAb))
Measured: Period I - On Day 1 (Randomization), 15, 29 and Period II - On day 1(Dosing)), 15, 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start31 May 2021
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Reddy's Laboratories Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885829
- Sponsor's protocol ID
- TC-01-002
- Status last verified
- May 2022
- First submitted
- 3 May 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04885829
- Acronym / sponsor ID
- TC-01-002
- Conditions
- Rheumatoid Arthritis, Giant Cell Arteritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- Dr. Reddy's Laboratories Limited
- Study start
- 31 May 2021 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 13 May 2021 (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.
A single dose, two period trial where participants will be given either of 3 Tocilizumab product on Day 1 during period 1 and either one of the remaining 2 Tocilizumab products on Day 1 period 2. There will be at least 6 weeks (42 days) of wash out between subsequent two period dosing. The maximum flexibility allowed between subsequent periods will be up to 9 weeks (63 days).
Names of the 3 tocilizumab products are DRL_TC, RP and RMP. So if a participant receives DRL_TC on Day 1 Period 1 then he/she will either receive RP/RMP on Day 1 Period 2.
Detailed description
The study will be conducted at 4 sites (2 in New Zealand, 1 in Australia and 1 in India) The three pairwise product comparisons (DRL_TC vs. RP; DRL_TC vs RMP and RP vs. RMP)will be performed in parallel. Each comparison will be separately considered. Study subjectswill be randomly assigned in a 1:1:1 ratio to one of the comparisons and within eachcomparison subjects will be randomized in a 1:1 ratio to one of the two possible productsequences The total duration of the individual subject study participation will be at least 12weeks. Dosing for period 1 will be on on day 1 followed by washout out period of upto 9weeks. Dosing for Period 2 will be on Day 1.
Subjects who complete the study and are found to be positive for anti-drug antibodies (ADA)on Day 29 and/or Day 43 period 2, will be followed up every 90 days for immunogenicitysampling up to approximately one year post Period II dosing, or until two consecutive sampleshave been negative for ADA, whichever is earlier. Early dropouts will be tested forimmunogenicity at the time of EOS and if they are positive for ADAs they will be followed-up ifpossible at 90 days intervals starting from the last received dose (either Period I or Period II) ina similar manner.
300 NHV (Normal Healthy Volunteers) will be included in the study as justified under samplesize justification. After the data of these 300 volunteers become available a blinded samplesize re-estimation (BSSR) will be performed to reconfirm the statistical assumptions of thestudy design and depending upon the outcome of the BSSR, study may be stopped or thesample size may be increased, as needed to attain the required statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRL_TC | Experimental | Drug: Tocilizumab Prefilled SyringeSubcutaneous injection of DRL's Tocilizumab |
| RP and RMP | Active comparator | Drug: Tocilizumab Prefilled SyringeSubcutaneous injection of Actemra and RoActemra (Commercially available Tocilizumab) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male and female volunteers, 18 to 50 years of age at the time of signing informed consent.
- In general good health as determined by a qualified physician based on a comprehensive medical history, physical examination including vital signs, laboratory haematology, clinical chemistry, urinalysis and 12-lead ECG during screening.
- BMI between 18.5 - 30.0 kg/m2 and body weight between 50 and 100 kg (both inclusive).
- Screening parameters (vital signs, physical examination, clinical laboratory tests, 12-lead ECG, chest X-ray, thyroid function etc.) are within the normal range or if outside the normal range, assessed as clinically non-significant by the Investigator (unless the value constitutes an explicit exclusion criterion).
- Male volunteers must be willing to abstain from sexual intercourse, sperm donation or willing to use in all relationships with a partner from the opposite sex a condom for the male partner and another effective method of contraception (such as an intra-uterine device, vaginal ring, oral contraceptive, injectable progesterone, or sub-dermal implant) for the female partner from the time of dosing until 3 months after the last dosing date, unless one of the partners is medically confirmed to be either infertile or surgically sterile.
Key exclusion criteria (27 listed)
- Positive test result for Quantiferon-TB Gold test, syphilis, hepatitis B, hepatitis C, or HIV-1 or 2.
- Any prior exposure to tocilizumab or to any other agent directly acting on interleukin-6 or on its receptors including investigational products (e.g. siltuximab, sarilumab etc.).
- Live virus vaccination within 3 months prior to screening or intention to receive live virus vaccination during the trial or up to 3 months after the administration of the study drug.
- Administration of immunoglobulins for anti-tetanus and antirabies post-exposure prophylaxis within 3 weeks prior to administration of study drug.
- History of immunodeficiency or other clinically significant immunological disorders, or auto-immune disorders, ongoing or frequent/ recurring infection defined as more than 3 per year requiring treatment or prior herpes zoster not fully healed (including the post-herpetic neuralgia period if occurring) within one year prior to randomization or history of systemic fungal infection at any time.
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 |
|---|---|---|
| Tocilizumab Prefilled SyringeAlso: Actemra, RoActemra0.9ml Subcutaneous pre-filled syringes containing 162mg of Tocilizumab. | Drug | DRL_TC, RP and RMP |
Primary outcome
To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP and RP vs RMP.
Time frame: Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days)
AUC0-∞ and AUC0-t will be calculated
To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP
Time frame: Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 days)
Cmax will be calculated
18 secondary outcomes
Safety assessment
Time frame: Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
Safety assessment
Time frame: Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
Safety assessment
Time frame: Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
Safety assessment
Time frame: Screening (Days -28 to -2), Day -1, predose (within 1hour before dosing), post dose (10 minutes, 60 minutes, 4 hours, 8 hours, 12 hours on day 1 and 43) and 24hours, 36hours, 48hours, 60 hours, 72 hours and 84hours after dosing
Safety assessment
Time frame: Screening (Day -28 to -2) to EOS visit
Safety assessment
Time frame: 2,24,36,48,60,72 and 84 hours post dosing.
Safety assessment
Time frame: Period I - Screening (Days -28 to -2), Day -1 (check- in), 1 (dosing),4, 5 and Period II - Day 1 (check- in), 1 (dosing) 4, 5 , 43 (-2 to +4 days)
Safety assessment
Time frame: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Time frame: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Time frame: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Time frame: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Time frame: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - Day 1 (check- in), 2 , 5 , 9, 15, 29, 43 (-2 to +4 days)
Safety assessment
Time frame: Period I - Screening (Days -28 to -2), check-in (day -1), 2, 5, 9, 15 and 29 and Period II - check-in (day -1), 2, 5, 9, 15, 29 ,43 (-2 to +4 days)
IL-6 assessment
Time frame: Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
hsCRP assessment
Time frame: Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
Neutrophil assessment
Time frame: Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
Lipid parameters assessment
Time frame: Period I - Day-1, 2, 5, 15 and Period II - Day -1 , 2 , 5 , 15
Immunogenicity assessment
Time frame: Period I - On Day 1 (Randomization), 15, 29 and Period II - On day 1(Dosing)), 15, 29
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 5 Jan 2024.
- Individual participant dataSharing planned: No
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tocilizumab Prefilled Syringe in people with Rheumatoid Arthritis and Giant Cell Arteritis, run by Syneos Health at 4 sites in 3 countries.
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 8 inclusion and 27 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in New Zealand, Australia, India. 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?
To demonstrate the PK (Pharmacokinetics) similarity of DRL_TC vs RP, DRL_TC vs RMP and RP vs RMP. (time frame: Period I pre-dose (1hour prior to drug administration), Days 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 18, 22, 29, 36, 43 and Period II - Day 1 (dosing), 2 ,3 , 4 , 5 , 6, 7, 9, 11, 15, 18, 22, 29 , 36 , 43 (-2 to +4 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?
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 5 Jan 2024.