Breast CancerPhase 3ChangHER-SCNCT01875367
Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer
A Phase 3 study testing Trastuzumab Injectable Solution, Trastuzumab Injectable Product and Trastuzumab Injection in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 27 sites in Spain.
Trial summary
GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within the SC by the administration through the vial or device self-administration in patients with disseminated breast cancer… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab Injectable Solution, Trastuzumab Injectable Product and Trastuzumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 27 sitesSpain
- Study dates
- 18 Sep 2013to 30 Apr 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman, 18 years old or upper.
- Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:
- immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)
- IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)
- FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria.
- Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.
Show all 12Show fewer
- No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2.
- Adequate bone marrow function, liver and kidney
- Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).
- The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.
- The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.
Who cannot join
- Patients with no advanced breast cancer.
- Breast cancer patients with tumors HER 2-negative.
- The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.
- The patient has uncontrolled brain metastases.
- Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.
- Known hypersensitivity to trastuzumab or to any of its components.
Show all 10Show fewer
- Patients with severe dyspnea at rest or requiring supplemental oxygen.
- Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.
- Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).
- The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Spain27 sites
Hospital Nuestra Señora de Sonsoles
Ávila, 05004
Hospital del Mar
Barcelona, 08003
Hospital Clinic i Provincial
Barcelona, 08036
Hospital Germans Trias i Pujol
Barcelona, 08916
Hospital Universitario Santa Lucía
Cartagena, Murcia, 30202
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28924
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital General Universitario de Granollers
Granollers, Barcelona, 08402
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, 25198
Hospital Universitario Lucus Augusti
Lugo, 27004
Hospital Universitario La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28021
Hospital de Manacor
Manacor, Balearic Islands, 07500
Hospital Costa del Sol
Marbella, Málaga, 29603
Hospital de Mataró
Mataró, Barcelona, 08304
Hospital Virgen del Puerto de Plasencia
Plasencia, Cáceres, 10600
Hospital Univesitario Quirón Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario San Joan de Reus
Reus, Tarragona, 43201
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Sant Joan Despí Moises Broggi
Sant Joan Despí, Barcelona, 08970
Hospital Universitario Virgen de la Macarena
Seville, 41009
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Virgen de la Salud
Toledo, 45004
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: Phase III Trial to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous (IV) Administration in HER2 Positive Advanced Breast Cancer Who Have Received IV Trastuzumab at Least 4 Months and Without Disease Progression
GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within the SC by the administration through the vial or device self-administration in patients with disseminated breast cancer HER2.
Read the detailed description
Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a syringe and 2 with the injection device). Following administration of these four cycles, the patient will decide whether or not to continue with the subcutaneous formulation of trastuzumab every 3 weeks until progression (out of the study). Since the randomization in the study until the start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous trastuzumab as usual.
Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs intravenous trastuzumab.
This principal primary objective will be analyzed with the answers to questionnaire of experiences and preferences of the patients (Principal endpoint) The duration of the study has been estimated after 34 months.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab Injectable Solution, Trastuzumab Injectable Product, Trastuzumab Injection
- Keywords
- Subcutaneous trastuzumab, Intravenous trastuzumab, HER2 positive, Advanced Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Injectable SolutionDrug
Also called Herceptin
Subcutaneous injection vial with a fixed dose of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) identical to that provided by the device. 3 weeks x 2 cycles.
Trastuzumab Injectable ProductDrug
Also called Herceptin
Single injection device is provided and loaded with the mixture of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) and is ready for use. 3 weeks x 2 cycles
Trastuzumab InjectionDrug
Also called Herceptin
Powder for concentrate for solution for infusion. 1 cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A: T-IV + T-SC vial + T-SC device | Experimental | Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles. Receives: Drug: Trastuzumab Injectable Solution; Drug: Trastuzumab Injectable Product; Drug: Trastuzumab Injection |
| Arm B: T-IV + T-SC device + T-SC vial | Experimental | Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles. Receives: Drug: Trastuzumab Injectable Solution; Drug: Trastuzumab Injectable Product; Drug: Trastuzumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference
The percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab was analyzed with the answer to the questionnaire C2, question number 39 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of experiences and preferences of the patient.
Measured: Up to 12 weeks
Secondary outcomes (5)
Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference
The percentage of patients who indicate a preference for the use of SC administration by vial or device was analyzed. This was discussed in the answer to questionaire C3, question number 28 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of the questionnaire of experiences and preferences of the patient.
Measured: Up to 12 weeks
Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference
The medical staff satisfaction was analyzed with the answers to question number 33a (Considering all aspects, with what method of administration were you more satisfied? Between Intravenous vs. Subcutaneous: Intravenous; Subcutaneous; No differences) of the questionnaire of experiences and preferences of the medical staff.
Health care professionals were not considered enrolled, but did contribute to this assessment.
Measured: Up to 12 weeks
Percentage of Medical Staff Subcutaneous Device vs. Vial Preference
The medical staff satisfaction was analyzed with the answers to question number 33b (Considering all aspects, with what method of administration were you more satisfied? Between Vial vs. Device: Preferred device; Preferred vial; No Preference) of the questionnaire of experiences and preferences of the medical staff. Health care professionals were not considered enrolled, but did contribute to this assessment.
Measured: Up to 12 weeks
Patient Time in Healthcare Unit and Sitting in Chair/Bed
Time spent by patient in the healthcare unit: Time between entrance and exit from the healthcare unit.
Time spent by patient sitting in the infusion/treatment chair/bed: Time between sitting and rising from the patient treatment chair/bed The data was collected by qualified observers from site staff that measured the time spent by healthcare professional using a chronometer, and write it down in the paper questionnaires or directly or after in the electronic case report form.
Measured: An average of 4 months
The Number of Participants Who Experienced Adverse Events (AE)
Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 4.03.
Measured: Through study treatment, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study start18 Sep 2013
- Primary completion30 Nov 2016
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients, from the randomization and before starting subcutaneous trastuzumab (SC-t), received an additional intravenous (IV-t) cycle. After receiving this cycle, patients started the treatment with the study medication, SC-t at a fixed dose of 600 mg every 3 weeks (+3 days) for 4 cycles (2 administered from the injection of a vial in a syringe and 2 with the single-use injection device \[SID\]), being randomized 1:1 in two arms of treatment without washout period: * Arm A (1 cycle of IV-t followed by 2 cycles of SC-t with vial followed by 2 cycles of SC-t with SID) * Arm B (1 cycle of IV-t followed by 2 cycles of SC-t with SID followed by 2 cycles of SC-t with vial) This is not a cross-over study.
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875367
- Sponsor's protocol ID
- GEICAM/2012-07
- Other IDs
- 2012-004928-38
- Acronym
- ChangHER-SC
- Status last verified
- Apr 2023
- First submitted
- 7 Jun 2013
- Last updated
- 5 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ciruelos EM, Montano A, Rodriguez CA, Gonzalez-Flores E, Lluch A, Garrigos L, Quiroga V, Anton A, Malon D, Chacon JI, Velasco M, Gonzalez-Cortijo L, Jolis L, Echarri MJ, Munoz M, Pascual T, Amigo Y, Casas M, Carrasco E, Casas A. Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07). Eur J Cancer Care (Engl). 2020 Jul;29(4):e13253. doi: 10.1111/ecc.13253. Epub 2020 Jun 23.
PubMed 32578279
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous (IV) Administration in HER2 Positive Advanced Breast Cancer Who Have Received IV Trastuzumab at Least 4 Months and Without Disease Progression
- ClinicalTrials.gov ID
- NCT01875367
- Acronym / sponsor ID
- ChangHER-SC / GEICAM/2012-07
- Conditions
- Breast Cancer
- Keywords
- Subcutaneous trastuzumab, Intravenous trastuzumab, HER2 positive, Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Study start
- 18 Sep 2013 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within the SC by the administration through the vial or device self-administration in patients with disseminated breast cancer HER2.
Detailed description
Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a syringe and 2 with the injection device). Following administration of these four cycles, the patient will decide whether or not to continue with the subcutaneous formulation of trastuzumab every 3 weeks until progression (out of the study). Since the randomization in the study until the start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous trastuzumab as usual.
Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs intravenous trastuzumab.
This principal primary objective will be analyzed with the answers to questionnaire of experiences and preferences of the patients (Principal endpoint) The duration of the study has been estimated after 34 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients, from the randomization and before starting subcutaneous trastuzumab (SC-t), received an additional intravenous (IV-t) cycle. After receiving this cycle, patients started the treatment with the study medication, SC-t at a fixed dose of 600 mg every 3 weeks (+3 days) for 4 cycles (2 administered from the injection of a vial in a syringe and 2 with the single-use injection device [SID]), being randomized 1:1 in two arms of treatment without washout period: * Arm A (1 cycle of IV-t followed by 2 cycles of SC-t with vial followed by 2 cycles of SC-t with SID) * Arm B (1 cycle of IV-t followed by 2 cycles of SC-t with SID followed by 2 cycles of SC-t with vial) This is not a cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Arm A: T-IV + T-SC vial + T-SC device | Experimental | Drug: Trastuzumab Injectable Solution, Drug: Trastuzumab Injectable Product, Drug: Trastuzumab InjectionTrastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles. |
| Arm B: T-IV + T-SC device + T-SC vial | Experimental | Drug: Trastuzumab Injectable Solution, Drug: Trastuzumab Injectable Product, Drug: Trastuzumab InjectionTrastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Woman, 18 years old or upper.
- Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:
- Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.
- No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2.
Key exclusion criteria (10 listed)
- Patients with no advanced breast cancer.
- Breast cancer patients with tumors HER 2-negative.
- The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.
- The patient has uncontrolled brain metastases.
- Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.
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 |
|---|---|---|
| Trastuzumab Injectable SolutionAlso: HerceptinSubcutaneous injection vial with a fixed dose of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) identical to that provided by the device. 3 weeks x 2 cycles. | Drug | Arm A: T-IV + T-SC vial + T-SC device, Arm B: T-IV + T-SC device + T-SC vial |
| Trastuzumab Injectable ProductAlso: HerceptinSingle injection device is provided and loaded with the mixture of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) and is ready for use. 3 weeks x 2 cycles | Drug | Arm A: T-IV + T-SC vial + T-SC device, Arm B: T-IV + T-SC device + T-SC vial |
| Trastuzumab InjectionAlso: HerceptinPowder for concentrate for solution for infusion. 1 cycle | Drug | Arm A: T-IV + T-SC vial + T-SC device, Arm B: T-IV + T-SC device + T-SC vial |
Primary outcome
Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference
Time frame: Up to 12 weeks
The percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab was analyzed with the answer to the questionnaire C2, question number 39 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of experiences and preferences of the patient.
5 secondary outcomes
Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference
Time frame: Up to 12 weeks
Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference
Time frame: Up to 12 weeks
Percentage of Medical Staff Subcutaneous Device vs. Vial Preference
Time frame: Up to 12 weeks
Patient Time in Healthcare Unit and Sitting in Chair/Bed
Time frame: An average of 4 months
The Number of Participants Who Experienced Adverse Events (AE)
Time frame: Through study treatment, an average of 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32578279Ciruelos EM, Montano A, Rodriguez CA, Gonzalez-Flores E, Lluch A, Garrigos L, Quiroga V, Anton A, Malon D, Chacon JI, Velasco M, Gonzalez-Cortijo L, Jolis L, Echarri MJ, Munoz M, Pascual T, Amigo Y, Casas M, Carrasco E, Casas A. Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07). Eur J Cancer Care (Engl). 2020 Jul;29(4):e13253. doi: 10.1111/ecc.13253. Epub 2020 Jun 23.
- Sponsor's webLink provided by the sponsor.
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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.
Study Director study director
Hospitales Universitarios Virgen del Rocío
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab Injectable Solution, Trastuzumab Injectable Product and Trastuzumab Injection in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 27 sites in Spain.
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 12 inclusion and 10 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference (time frame: Up to 12 weeks). 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 NCT01875367, which also lists 1 linked publication.
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 Apr 2023.