PainPhase 1/2NCT03607903
Adalimumab Microneedles in Healthy Volunteers
A Phase 1/2 study testing Adalimumab ID, Adalimumab SC and Saline ID in people with Pain and Injection Site, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.
Trial summary
Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA). Adalimumab works by binding to tumor necrosis factor alpha (TNF), hereby preventing its interaction with the TNF receptor. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Injection Site
- What is being tested?
- Adalimumab ID, Adalimumab SC and Saline ID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Jul 2018to 30 Oct 2018
- Phase
- Phase 1/2
- 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
- Eligible subjects must meet all of the following inclusion criteria at screening:
- Healthy male / female subjects, 18 to 45 years of age, inclusive at screening;
- Good health, based upon the results of medical history, physical examination, vital signs, ECG, and laboratory profiles of both blood and urine;
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg;
- Willing to practice an approved method of birth control and not breastfeeding throughout the study and for five months after study drug administration, as advised in the drug formulary (2). If the trial subject is female, surgical sterilization or postmenopausal status for >1 year will satisfy this requirement. All female subjects are required to have a negative pregnancy test at screening and at baseline (pre-dose);
- Fitzpatrick skin type I-II (Caucasian type);
- Suitable site for intradermal injection on the legs, as assessed by the investigator;
- Able and willing to provide written informed consent.
Who cannot join
- Eligible subjects must meet none of the following exclusion criteria at screening:
- Immune-compromised (known or expected immune deficiency, disease, or use of medication that may affect the immune system);
- Diagnosed with tuberculosis (TB, as per positive skin test [Mantoux] or interferon gamma release assay), or history of TB, or latent TB, or recent contact with TB (patient); having travelled to countries where TB is endemic within eight weeks of planned drug administration or planning to travel to countries where TB is endemic from the moment of drug administration until three months after the end of the study;
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug (including adalimumab);
- History of chronic infection, or infections within the past two years requiring hospitalization or administration of intravenous antibiotics;
- Receipt of any live vaccination within three months prior to study drug administration, or intention to undergo live vaccinations from the moment of drug administration until four months after the end of study;
Show all 20Show fewer
- Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening;
- Evidence of any active or chronic disease (hematologic, renal, hepatic, cardiovascular, neurologic, endocrinal, gastrointestinal, oncologic, pulmonary, immunologic, or psychiatric disorder) or condition that could interfere with, or for which the treatment of might interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, and body temperature) and ECG). Minor deviations from the normal range may be accepted, if judged by the investigator to have no clinical relevance;
- History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent;
- Consumption of alcohol within the 48-hour period prior to study drug administration;
- Smoke more than 10 cigarettes per day prior to screening or use tobacco products equivalent to more than 10 cigarettes per day and/or unable to abstain from smoking whilst in the unit;
- Positive screen for recreational drugs or alcohol;
- Is demonstrating excess in xanthine consumption (more than eight cups of coffee or equivalent per day);
- Unlikely to comply with the study protocol and/or to complete the study or required study procedures, including being unlikely or unable to return for follow-up visits;
- Use of any medication (prescription or over-the-counter (OTC) within 14 days of study drug administration, or use of herbal supplements, dietary supplements or multivitamins within 7 days of study drug administration or less than five half-lives (whichever is longer), or receipt of any drug by injection within 30 days of study drug administration, with the exception of contraceptives, hormonal replacement therapies, and paracetamol (up to 4g/day). Other exceptions will only be made if the rationale is clearly documented by the investigator;
- Donation of over 500 mL of blood within three months prior to screening or donation of plasma within 14 days prior to screening;
- Previous exposure to any biological;
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
- Excessive sun exposure of the injection site area within 3 weeks of enrollment;
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive adalimumab or otherwise participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Double-dummy Study to Assess Microneedle Delivery in Comparison to Subcutaneous Injection of Adalimumab in Healthy Volunteers
Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA). Adalimumab works by binding to tumor necrosis factor alpha (TNF), hereby preventing its interaction with the TNF receptor. In the presence of complement, adalimumab can also lyse TNF-expressing cells.
Adalimumab is administered via subcutaneous injection, which has the major drawback of being perceived as unpleasant and painful, especially during long term use for both adults and children. As subcutaneous administration may therefore eventually jeopardize treatment adherence, there is a clear need for less invasive alternatives to administer highly effective biological drugs such as adalimumab.
Read more
Microneedles may be a potential alternative for invasive drug administration. Microneedles are currently widely investigated for the administration of various vaccines. The experience with administration of biological drugs is rather limited. The sparse available data suggests similar pharmacokinetics of adalimumab when administered either subcutaneous or intradermal in healthy volunteers. Moreover, the first studies report good tolerability of microneedles. However, no systematic studies have been performed yet i) to investigate pain, acceptability, and local tolerability for intradermal versus subcutaneous adalimumab administration ii) to evaluate safety, PK and immunogenicity for intradermal versus subcutaneous adalimumab and iii) to explore the usability of optical coherence tomography, clinical photography, thermal imaging and laser speckle contrast imaging in the evaluation of intradermal injections.
This study will directly compare the pain perception and hence acceptability of a single dose (40 mg) of adalimumab administered subcutaneously (SC) versus intradermally (ID) via microneedles in healthy adult volunteers. Furthermore, the pharmacokinetic profile, pharmacodynamics, the immunogenicity and the tolerability will be assessed. This study will enable bridging to a future study in children and adolescents with JIA, in which the suitability of microneedles for the administration of adalimumab in pediatric patients will be examined. The overarching aim of these studies is to make administration of biologicals in children as pain free as possible.
Read the detailed description
Objective(s)
- To evaluate the pain, acceptability and local tolerability of intradermal microneedle injection compared to subcutaneous injection in healthy volunteers.
- To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of adalimumab after administration using microneedles versus subcutaneous injection in healthy volunteers.
- To explore the usability of optical coherence tomography, clinical photography, laser speckle contrast imaging, and thermal imaging in the evaluation of intradermal injections.
Definitions Method: ID or SC injection Compound: adalimumab or saline Treatment: combination of method and compound Arm: sequence of treatments
Design This is a double blind, placebo controlled, double-dummy study. The study physician will administer the injection and is thus unblinded to the type of injection. All injection site assessments will be performed by (a) study independent member of the clinical staff.
Sterile saline injection will be used as a negative control. Subjects will receive an injection with both sterile saline (SC or ID) and adalimumab (SC or ID). Subjects will be randomized to one of the four arms:
1A) adalimumab SC and saline ID
- B) saline ID and adalimumab SC
- A) saline SC and adalimumab ID
2B) adalimumab ID and saline SC
The maximum duration between treatments will be 5 minutes.
After a single dose of adalimumab, pharmacokinetic, pharmacodynamics, tolerability and immunogenicity data will be collected and monitored for a total of 70 days post dose, as the half-life of adalimumab after subcutaneous injection in adults is approximately two weeks.
Investigational drug/device combination In children, adalimumab is commonly used in a dose of 40 mg SC every two weeks (1). For adults with rheumatoid arthritis the same dose is used (2). It was therefore chosen to administer adalimumab in a single dose of 40 mg in 0.4 mL either subcutaneously or intradermally in the upper thigh. For saline injection the same volume will be used.
For intradermal administration, the MicronJet600 (NanoPass Technologies) will be used (hereafter referred to as microneedle). This CE-marked microneedle consists of an array of three hollow pyramid-shaped microneedles with a length of 600 micrometer (3).
Subjects / Groups A total of 24 healthy subjects (N=6 per arm and N=12 per treatment (Adalimumab SC, Adalimumab ID, Saline SC, Saline ID).
- Conditions
- Pain, Injection Site
- Being tested
- Adalimumab ID, Adalimumab SC, Saline ID, Saline SC
- Keywords
- intradermal, adalimumab, microneedle, subcutaneous, healthy volunteers
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab IDBiological
Adalimumab intradermal using MicronJet600 microneedle from NanoPass
Adalimumab SCBiological
Adalimumab subcutaneous using regular needle
Saline IDOther
Saline intradermal using MicronJet600 microneedle from NanoPass
Saline SCOther
Saline subcutaneous using regular needle
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous adalimumab and placebo | Active comparator | adalimumab SC (40 mg in 0.4 mL) and saline ID (0.9%, 0.4 mL) Receives: Biological: Adalimumab SC; Other: Saline ID |
| PLacebo and subcutaneous adalimumab | Active comparator | saline ID (0.9%, 0.4 mL) and adalimumab SC (40 mg in 0.4 mL) Receives: Biological: Adalimumab SC; Other: Saline ID |
| Placebo and intradermal adalimumab | Experimental | saline SC (0.9%, 0.4 mL) and adalimumab ID (40 mg in 0.4 mL) Receives: Biological: Adalimumab ID; Other: Saline SC |
| Intradermal adalimumab and placebo | Experimental | adalimumab ID (40 mg in 0.4 mL) and saline SC (0.9%, 0.4 mL) Receives: Biological: Adalimumab ID; Other: Saline SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of pain
Pain will be measured using a standard 100 points visual analogue scale (0: no pain, 100: extreme pain).
Insertion, injection and post-injection pain will be assessed separately.
Measured: 7 weeks
Adalimumab pharmacokinetics
Individual serum adalimumab concentrations will be plotted versus time per individual.
Measured: 10 weeks
Anti-adalimumab antibodies
All subjects who received study medication will be monitored for serum anti-adalimumab antibodies.
Measured: 10 weeks
Ex vivo cytokine levels
Ex vivo whole blood challenge will be performed to assess the effect of adalimumab on the release of cytokines by circulating immune cells and activation of these cells. Whole blood will be stimulated with 2ng/mL lipopolysaccharide and 25 ug/mL aluminium ydroxide for 24 hours at 37 degrees Celsius, 5% carbon dioxide. Culture supernatants will be assayed for release of pro-inflammatory cytokines including tumor necrosis factor alpha, interleukin 6, interleukin 1 beta, interleukin 8, and interferon gamma.
Measured: 10 weeks
Amount of pain
Pain will be measured using Dutch version of the faces pain scales revised (0-2-4-6-8-10, 0: no pain, 10: very much pain).
Insertion, injection and post-injection pain will be assessed separately.
Measured: 7 weeks
Secondary outcomes (3)
Preference for subjects for either injection (SC versus ID)
Subjects will be asked multiple choice questions on the acceptability of both injections.
Measured: 2 days
Number of injection site reactions
Injection site assessment for the following:
Pain (grade 1/2/3) Tenderness (grade 1/2/3) Pruritus (grade 1/2/3) Erythema (absent/present) Induration (grade 1/2/3) Blister (absent/present) Ulceration (absent/present) Necrosis (absent/present) Ecchymosis (absent/present) If any of these signs or symptoms is present, it is regarded an injection site reaction.
Measured: 10 weeks
Number of (serious) adverse events per treatment arm
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start11 Jul 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blind, placebo controlled, double-dummy study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Human Drug Research, Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Leiden Academic Center for Drug Research, the Netherlands
- Responsible party
- Sponsor
- Investigators
- Robert Rissmann, RPh PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607903
- Sponsor's protocol ID
- CHDR1807
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2018
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: CHDR will provide NanoPass with a written report summarizing the results of the Clinical Study such as the publication or manuscript, including but not limited to, promptly sharing any severe or potentially reportable safety or adverse event potentially related to the MicronJet600.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Double-dummy Study to Assess Microneedle Delivery in Comparison to Subcutaneous Injection of Adalimumab in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03607903
- Acronym / sponsor ID
- CHDR1807
- Conditions
- Pain, Injection Site
- Keywords
- intradermal, adalimumab, microneedle, subcutaneous, healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre for Human Drug Research, NetherlandsUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Leiden Academic Center for Drug Research, the Netherlands
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 31 Jul 2018 (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.
Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA). Adalimumab works by binding to tumor necrosis factor alpha (TNF), hereby preventing its interaction with the TNF receptor. In the presence of complement, adalimumab can also lyse TNF-expressing cells.
Adalimumab is administered via subcutaneous injection, which has the major drawback of being perceived as unpleasant and painful, especially during long term use for both adults and children. As subcutaneous administration may therefore eventually jeopardize treatment adherence, there is a clear need for less invasive alternatives to administer highly effective biological drugs such as adalimumab.
Microneedles may be a potential alternative for invasive drug administration. Microneedles are currently widely investigated for the administration of various vaccines. The experience with administration of biological drugs is rather limited. The sparse available data suggests similar pharmacokinetics of adalimumab when administered either subcutaneous or intradermal in healthy volunteers. Moreover, the first studies report good tolerability of microneedles. However, no systematic studies have been performed yet i) to investigate pain, acceptability, and local tolerability for intradermal versus subcutaneous adalimumab administration ii) to evaluate safety, PK and immunogenicity for intradermal versus subcutaneous adalimumab and iii) to explore the usability of optical coherence tomography, clinical photography, thermal imaging and laser speckle contrast imaging in the evaluation of intradermal injections.
This study will directly compare the pain perception and hence acceptability of a single dose (40 mg) of adalimumab administered subcutaneously (SC) versus intradermally (ID) via microneedles in healthy adult volunteers. Furthermore, the pharmacokinetic profile, pharmacodynamics, the immunogenicity and the tolerability will be assessed. This study will enable bridging to a future study in children and adolescents with JIA, in which the suitability of microneedles for the administration of adalimumab in pediatric patients will be examined. The overarching aim of these studies is to make administration of biologicals in children as pain free as possible.
Detailed description
Objective(s)
- To evaluate the pain, acceptability and local tolerability of intradermal microneedle injection compared to subcutaneous injection in healthy volunteers.
- To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of adalimumab after administration using microneedles versus subcutaneous injection in healthy volunteers.
- To explore the usability of optical coherence tomography, clinical photography, laser speckle contrast imaging, and thermal imaging in the evaluation of intradermal injections.
Definitions Method: ID or SC injection Compound: adalimumab or saline Treatment: combination of method and compound Arm: sequence of treatments
Design This is a double blind, placebo controlled, double-dummy study. The study physician will administer the injection and is thus unblinded to the type of injection. All injection site assessments will be performed by (a) study independent member of the clinical staff.
Sterile saline injection will be used as a negative control. Subjects will receive an injection with both sterile saline (SC or ID) and adalimumab (SC or ID). Subjects will be randomized to one of the four arms:
1A) adalimumab SC and saline ID
- B) saline ID and adalimumab SC
- A) saline SC and adalimumab ID
2B) adalimumab ID and saline SC
The maximum duration between treatments will be 5 minutes.
After a single dose of adalimumab, pharmacokinetic, pharmacodynamics, tolerability and immunogenicity data will be collected and monitored for a total of 70 days post dose, as the half-life of adalimumab after subcutaneous injection in adults is approximately two weeks.
Investigational drug/device combination In children, adalimumab is commonly used in a dose of 40 mg SC every two weeks (1). For adults with rheumatoid arthritis the same dose is used (2). It was therefore chosen to administer adalimumab in a single dose of 40 mg in 0.4 mL either subcutaneously or intradermally in the upper thigh. For saline injection the same volume will be used.
For intradermal administration, the MicronJet600 (NanoPass Technologies) will be used (hereafter referred to as microneedle). This CE-marked microneedle consists of an array of three hollow pyramid-shaped microneedles with a length of 600 micrometer (3).
Subjects / Groups A total of 24 healthy subjects (N=6 per arm and N=12 per treatment (Adalimumab SC, Adalimumab ID, Saline SC, Saline ID).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a double blind, placebo controlled, double-dummy study.
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous adalimumab and placebo | Active comparator | Biological: Adalimumab SC, Other: Saline IDadalimumab SC (40 mg in 0.4 mL) and saline ID (0.9%, 0.4 mL) |
| PLacebo and subcutaneous adalimumab | Active comparator | Biological: Adalimumab SC, Other: Saline IDsaline ID (0.9%, 0.4 mL) and adalimumab SC (40 mg in 0.4 mL) |
| Placebo and intradermal adalimumab | Experimental | Biological: Adalimumab ID, Other: Saline SCsaline SC (0.9%, 0.4 mL) and adalimumab ID (40 mg in 0.4 mL) |
| Intradermal adalimumab and placebo | Experimental | Biological: Adalimumab ID, Other: Saline SCadalimumab ID (40 mg in 0.4 mL) and saline SC (0.9%, 0.4 mL) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male / female subjects, 18 to 45 years of age, inclusive at screening;
- Good health, based upon the results of medical history, physical examination, vital signs, ECG, and laboratory profiles of both blood and urine;
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg;
- Willing to practice an approved method of birth control and not breastfeeding throughout the study and for five months after study drug administration, as advised in the drug formulary (2). If the trial subject is female, surgical sterilization or postmenopausal status for >1 year will satisfy this requirement. All female subjects are required to have a negative pregnancy test at screening and at baseline (pre-dose);
- Fitzpatrick skin type I-II (Caucasian type);
Key exclusion criteria (20 listed)
- Immune-compromised (known or expected immune deficiency, disease, or use of medication that may affect the immune system);
- Diagnosed with tuberculosis (TB, as per positive skin test [Mantoux] or interferon gamma release assay), or history of TB, or latent TB, or recent contact with TB (patient); having travelled to countries where TB is endemic within eight weeks of planned drug administration or planning to travel to countries where TB is endemic from the moment of drug administration until three months after the end of the study;
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug (including adalimumab);
- History of chronic infection, or infections within the past two years requiring hospitalization or administration of intravenous antibiotics;
- Receipt of any live vaccination within three months prior to study drug administration, or intention to undergo live vaccinations from the moment of drug administration until four months after the end of study;
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 |
|---|---|---|
| Adalimumab IDAdalimumab intradermal using MicronJet600 microneedle from NanoPass | Biological | Intradermal adalimumab and placebo, Placebo and intradermal adalimumab |
| Adalimumab SCAdalimumab subcutaneous using regular needle | Biological | PLacebo and subcutaneous adalimumab, Subcutaneous adalimumab and placebo |
| Saline IDSaline intradermal using MicronJet600 microneedle from NanoPass | Other | PLacebo and subcutaneous adalimumab, Subcutaneous adalimumab and placebo |
| Saline SCSaline subcutaneous using regular needle | Other | Intradermal adalimumab and placebo, Placebo and intradermal adalimumab |
Primary outcome
Amount of pain
Time frame: 7 weeks
Pain will be measured using a standard 100 points visual analogue scale (0: no pain, 100: extreme pain). Insertion, injection and post-injection pain will be assessed separately.
Adalimumab pharmacokinetics
Time frame: 10 weeks
Individual serum adalimumab concentrations will be plotted versus time per individual.
Anti-adalimumab antibodies
Time frame: 10 weeks
All subjects who received study medication will be monitored for serum anti-adalimumab antibodies.
Ex vivo cytokine levels
Time frame: 10 weeks
Ex vivo whole blood challenge will be performed to assess the effect of adalimumab on the release of cytokines by circulating immune cells and activation of these cells. Whole blood will be stimulated with 2ng/mL lipopolysaccharide and 25 ug/mL aluminium ydroxide for 24 hours at 37 degrees Celsius, 5% carbon dioxide. Culture supernatants will be assayed for release of pro-inflammatory cytokines including tumor necrosis factor alpha, interleukin 6, interleukin 1 beta, interleukin 8, and interferon gamma.
Amount of pain
Time frame: 7 weeks
Pain will be measured using Dutch version of the faces pain scales revised (0-2-4-6-8-10, 0: no pain, 10: very much pain). Insertion, injection and post-injection pain will be assessed separately.
3 secondary outcomes
Preference for subjects for either injection (SC versus ID)
Time frame: 2 days
Number of injection site reactions
Time frame: 10 weeks
Number of (serious) adverse events per treatment arm
Time frame: 10 weeks
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 3 Aug 2021.
- Individual participant dataSharing planned: No. CHDR will provide NanoPass with a written report summarizing the results of the Clinical Study such as the publication or manuscript, including but not limited to, promptly sharing any severe or potentially reportable safety or adverse event potentially related to the MicronJet600.
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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.
Robert Rissmann, RPh PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adalimumab ID, Adalimumab SC and Saline ID in people with Pain and Injection Site, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.
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 20 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 3 Aug 2021. 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 Netherlands. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Amount of pain (time frame: 7 weeks). The study lists 5 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 3 Aug 2021.