Rheumatoid Arthritis AggravatedPhase 1/2NCT01663116
Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients
A Phase 1/2 study testing Stem cells in people with Rheumatoid Arthritis Aggravated, run by Tigenix S.A.U. at 23 sites in Spain.
Trial summary
Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with three treatment groups, controlled with placebo (randomization 3:1) whose target population are patients with rheumatoid arthritis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis Aggravated
- What is being tested?
- Stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 23 sitesSpain
- Study dates
- Mar 2011to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all the following inclusion criteria to be eligible for study entry:
- Must understand and voluntarily sign an informed consent form prior to the conduct of any study related assessment/procedures.
- Subjects with RA under treatment with at least one non-biologic-DMARD and failure to treatment with at least two biologics.
- Of either gender, aged ≥ 18 years at time of consent.
- Able to adhere to the study visit schedule and other protocol requirements.
- Have a diagnosis of RA for ≥6 months.
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- EULAR DAS28-ESR activity criteria >3.2.
- Four tender joints to palpation and four swollen joints, based on a 68/66-joint count.
- Be receiving treatment on an outpatient basis.
- If taking methotrexate, leflunomide, or sulfasalazine, must have been treated for at least 16 weeks and on a stable dose (oral methotrexate ≤ 25 mg/week; parenteral methotrexate ≤ 20 mg/week; leflunomide ≤ 20 mg/day; sulfasalazine ≤ 3 g/day) for at least 4 weeks prior to the start of treatment and throughout the study. (See also section 7.5). The rest of the DMARDs (gold salts, etc) should be maintained at stable doses during at least the 4 weeks prior to the start of treatment and throughout the study (see also section 7.5).
- If taking oral corticosteroids, must be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 1 month prior to screening. ( See also section 7.5).
- If taking NSAIDs, must be on stable dose for at least 2 weeks prior to screening and until they have completed the Week 24 study visit. (See also section 7.5).
- Male subjects (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in activity in which conception is possible while on study medication and for at least 28 days after taking the last dose of study medication.
- Females of Childbearing Potential* must have a negative urine pregnancy test at Screening and Baseline and must be willing to use one medically approved form of birth control when engaging in activity in which conception is possible while on study medication and for at least 28 days after taking the last dose of study medication.
- A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral ovariectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).
Who cannot join
- A patient CANNOT be recruited into this study if any of the following criteria is met:
- Treatment with biologics within the following period prior to the start of treatment:
- Infliximab: 8 weeks
- Etanercept: 2 weeks
- Adalimumab and certolizumab: 4 weeks
- Abatacept, tocilizumab and golimumab: 8 weeks
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- Rituximab: 6 months
- Anakinra: 3 days No treatment with biologics is allowed during the first 12 weeks after the start of the study treatment. Thus, the patients should have complied with the periods indicated above, and should not receive any biologics during the period specified.
- Presence of a severe bleeding or thrombotic disorder.
- History of known pulmonary embolism or known secondary anti-phospholipid syndrome.
- Received any of the following treatments within 2 years prior to study entry: anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies for malignancy).
- Received within 4 weeks prior to the start of treatment: intra-articular, intramuscular or intravenous corticosteroids. (See also section 7.5).
- Past or current malignant melanoma.
- Past or current malignancy; except for in situ cervical cancer, non-invasive basal cell and squamous cell skin carcinoma, superficial bladder tumors (Ta and Tis) with a complete response duration of >10 years. In the case of lymphoma or breast cancer patients will be allowed to participate in the trial with a complete response duration of >20 years.
- Other autoimmune diseases, previous or current inflammatory joint disease other than rheumatoid arthritis, currently active or previous recurrent bacterial, viral, fungal, or other infections including, but not limited to, tuberculosis and atypical mycobacterial disease, clinically significant abnormalities on chest radiograph, hepatitis B and C, and recurrent herpes zoster.
- Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, Mycobacterium tuberculosis infection (TB) and active hepatitis B and C.
- For the screening of latent TB, the results of the tests performed in the last year according to the usual practice of the center or local guidelines will be accepted, as long as the investigator rules out a situation of high contact risk in the months after the last screening in accordance with the medical history of the patient.
- If the patient has a recent chest X-ray (performed in the month prior to enrollment in the study) and there is no clinical evidence or history suggestive of recent contact, it will not be necessary to repeat the test.
- Subjects with signs of latent TB can be included if they have started treatment according to local guidelines at least one month prior to starting investigational therapy.
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II of the New York criteria.
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease.
- History of significant cerebrovascular disease.
- Subjects with congenital or acquired immunodeficiencies.
- Known human immunodeficiency virus (HIV) positive.
- Screening laboratory values (according to central laboratory):
- Haemoglobin <5.6 mmol/L (9.0 g/dL).
- Neutrophils <1.5 x 10(9)/L.
- Leukocytes <3.0 x 10(9)/L.
- Platelets <100 x 10(9)/L.
- Serum IgG <lower limit of normal (LLN).
- Alanine amino transferase (ALT) > 1.5 times the upper limit of normal (ULN).
- Total bilirubin >2 mg/dl.
- Aspartate amino transferase (AST) >1.5 times ULN.
- Alkaline phosphatase (ALP) >2 times ULN.
- Creatinine >133 mmol/L (1.5 mg/dL).
- Serologic evidence of hepatitis C (HC) infection.
- Serologic evidence of hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs antibodies as follows:
- Subjects positive for HBsAg are excluded.
- Subjects negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies were eligible to participate.
- Subjects negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody are eligible to participate.
- Subjects negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody required clarification of their status by testing for HB DNA which if positive excludes the subject from participation.
- Patients with documented vaccination against hepatitis B (primary and secondary immunization and booster) are considered negative.
- Receipt of any vaccination (live, attenuated or killed) in 8 wks prior to baseline.
- Subjects who had received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to screening.
- Current participation in any other interventional clinical study.
- Subjects known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
- MRI is unfeasible, (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia).
- Subjects with impossibility of having a radiological exploration.
- Known allergies or hypersensitivity to antibiotics, HSA, DMEM, materials of bovine origin, gadolinium (MRI contrast) and Ringer's Lactate Solution.
- Pregnancy and breastfeeding.
- Any other condition which the PI judges would make patient unsuitable for study participation.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Spain23 sites
Complejo Hospitalario U. A Coruña
A Coruña, 15006
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, 08036
Hospital Santa Creu i Sant Pau
Barcelona, 08041
Hospital de Basurto
Bilbao, Vizcaya, 48013
Hospital Reina Sofía
Córdoba, 14004
Hospital Clínico San Cecilio
Granada, 18012
Hospital U. Virgen de las Nieves
Granada, 18014
Hospital U. de Guadalajara
Guadalajara, 19002
Hospital de La Princesa
Madrid, 28006
Hospital U. Gregorio Marañon
Madrid, 28007
Hospital Clínico San Carlos
Madrid, 28040
Hospital U. La Paz
Madrid, 28046
Hospital Carlos Haya
Málaga, 29010
Hospital General de Mérida
Mérida, Badajoz, 06800
Hospital U. Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital U. de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital U. Marques de Valdecilla
Santander, 39008
Hospital Ntra. Sª de Valme
Seville, 41014
Hospital Virgen Macarena
Seville, 41071
Hospital La Fe
Valencia, 46009
Hospital Dr. Peset
Valencia, 46017
About this study
Official title: "Phase Ib/IIa, Escalating Dose, Single Blind, Clinical Trial to Assess the Safety of the i.v Administration of Allogeneic Adipose-derived Mesenchymal Cells (eASCs) to Refractory Rheumatoid Arthritis (RA) Patients".
Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with three treatment groups, controlled with placebo (randomization 3:1) whose target population are patients with rheumatoid arthritis refractory to at least two biologic.
Read the detailed description
Traditionally, RA has been treated with non-steroidal anti-inflammatory drugs, glucocorticoids and non-biologics-DMARDs. Only non-biologics-DMARDs and, at a lesser extent, glucocorticoids have shown to be able to prevent or interrupt the inflammatory and destructive disease processes.
Mesenchymal stem cells (MSCs) are nonhematopoietic stromal cells that are able to differentiate into mesenchymal tissues such as bone, cartilage, muscle, ligament, tendon, and adipose. MSCs can be easily isolated from bone marrow or adipose tissue and rapidly expanded in culture. MSCs have also been shown to have immuno-suppressive and healing capacities, improve angiogenesis and prevent fibrosis. These properties could be used for novel therapeutic applications in various disorders, including rheumatoid arthritis, osteoarthritis (OA), genetic bone and cartilage disorders and bone metastasis. MSCs can potently modulate immune responses, showing antiproliferative and anti-inflammatory capacities.
This study is a multicenter phase Ib/IIa, escalating dose, single blind clinical trial to assess the safety of the intravenous administration of expanded allogeneic adipose-derived mesenchymal stem cells (eASCs) to refractory rheumatoid arthritis (RA) patients.
The primary objective of the study is to determine the safety, feasibility and tolerance, and to identify, if possible, the dose limiting toxicity (DLT) and the dose for future clinical trials on efficacy of the intravenous infusion of allogeneic eASCs for patients suffering rheumatoid arthritis (RA) under treatment with at least one non-biologic-Disease modifying antirheumatoid drug (DMARD) who have previously failed to treatment with at least two biologics. The secondary objective is to obtain information on the clinical and functional effects of the intravenous infusion of allogeneic eASCs in patients with RA and to explore pharmacodynamics parameters.
53 patients (i.e. patients having received at least one dose of study treatment) in three different cohorts are planned to be included in this clinical trial. Expansion will start after acute toxicity assessment of the first three patients of each cohort.
Dose and intervals for the trial consist of the following active groups: a) first cohort: 1 million cells/kg administered at days 1, 8 and 15; b) second cohort: 2 million cells / kg administered at days 1, 8 and 15; c) third cohort: 4 million cells / kg administered at days 1, 8 and 15.
- Conditions
- Rheumatoid Arthritis Aggravated
- Being tested
- Stem cells, Placebo
- Keywords
- Rheumatoid arthritis, Expanded adipose derived allogeneic adult stem cells (eASCs)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cellsGenetic
- first cohort: 1 million stem cells/kg administered at days 1, 8 and 15
- second cohort: 2 million stem cells / kg administered at days 1, 8 and 15
- third cohort: 4 million stem cells / kg administered at days 1, 8 and 15
PlaceboGenetic
- first cohort: 20 ml administered at days 1, 8 and 15
- second cohort: 40 ml administered at days 1, 8 and 15
- third cohort: 80 ml administered at days 1, 8 and 15
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 1. first cohort: 1 million stem cells/kg administered at days 1, 8 and 15
2. second cohort: 2 million stem cells / kg administered at days 1, 8 and 15
3. third cohort: 4 million stem cells / kg administered at days 1, 8 and 15 Receives: Genetic: Stem cells |
| Placebo | Placebo comparator | Lactate Ringer´s solution Receives: Genetic: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events and Severe Adverse Events
Total number of Adverse Events and Severe Adverse Events, related and non-related with the medication will be recorded as a measure of tolerability and safety.
Measured: 6 months follow up after the first administration
Secondary outcomes (1)
Proportion of ACR20 patients/ACR50 patients/ACR70 patients (swollen joints*, tender joints**, physician global assessment***, patient global assessment***, patient´s assessment of pain ***, ESR/CRP, HAQ score)
Measured: At selection and screening visit, and once per month during 6 months after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis AggravatedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tigenix S.A.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José María Alvaro-Gracia, MD, PhD, Study chair, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663116
- Sponsor's protocol ID
- Cx611-0101
- Status last verified
- Apr 2019
- First submitted
- 5 Aug 2011
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alvaro-Gracia JM, Jover JA, Garcia-Vicuna R, Carreno L, Alonso A, Marsal S, Blanco F, Martinez-Taboada VM, Taylor P, Martin-Martin C, DelaRosa O, Tagarro I, Diaz-Gonzalez F. Intravenous administration of expanded allogeneic adipose-derived mesenchymal stem cells in refractory rheumatoid arthritis (Cx611): results of a multicentre, dose escalation, randomised, single-blind, placebo-controlled phase Ib/IIa clinical trial. Ann Rheum Dis. 2017 Jan;76(1):196-202. doi: 10.1136/annrheumdis-2015-208918. Epub 2016 Jun 7.
PubMed 27269294
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Phase Ib/IIa, Escalating Dose, Single Blind, Clinical Trial to Assess the Safety of the i.v Administration of Allogeneic Adipose-derived Mesenchymal Cells (eASCs) to Refractory Rheumatoid Arthritis (RA) Patients".
- ClinicalTrials.gov ID
- NCT01663116
- Acronym / sponsor ID
- Cx611-0101
- Conditions
- Rheumatoid Arthritis Aggravated
- Keywords
- Rheumatoid arthritis, Expanded adipose derived allogeneic adult stem cells (eASCs)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Tigenix S.A.U.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Aug 2012 (estimated)
- 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.
Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with three treatment groups, controlled with placebo (randomization 3:1) whose target population are patients with rheumatoid arthritis refractory to at least two biologic.
Detailed description
Traditionally, RA has been treated with non-steroidal anti-inflammatory drugs, glucocorticoids and non-biologics-DMARDs. Only non-biologics-DMARDs and, at a lesser extent, glucocorticoids have shown to be able to prevent or interrupt the inflammatory and destructive disease processes.
Mesenchymal stem cells (MSCs) are nonhematopoietic stromal cells that are able to differentiate into mesenchymal tissues such as bone, cartilage, muscle, ligament, tendon, and adipose. MSCs can be easily isolated from bone marrow or adipose tissue and rapidly expanded in culture. MSCs have also been shown to have immuno-suppressive and healing capacities, improve angiogenesis and prevent fibrosis. These properties could be used for novel therapeutic applications in various disorders, including rheumatoid arthritis, osteoarthritis (OA), genetic bone and cartilage disorders and bone metastasis. MSCs can potently modulate immune responses, showing antiproliferative and anti-inflammatory capacities.
This study is a multicenter phase Ib/IIa, escalating dose, single blind clinical trial to assess the safety of the intravenous administration of expanded allogeneic adipose-derived mesenchymal stem cells (eASCs) to refractory rheumatoid arthritis (RA) patients.
The primary objective of the study is to determine the safety, feasibility and tolerance, and to identify, if possible, the dose limiting toxicity (DLT) and the dose for future clinical trials on efficacy of the intravenous infusion of allogeneic eASCs for patients suffering rheumatoid arthritis (RA) under treatment with at least one non-biologic-Disease modifying antirheumatoid drug (DMARD) who have previously failed to treatment with at least two biologics. The secondary objective is to obtain information on the clinical and functional effects of the intravenous infusion of allogeneic eASCs in patients with RA and to explore pharmacodynamics parameters.
53 patients (i.e. patients having received at least one dose of study treatment) in three different cohorts are planned to be included in this clinical trial. Expansion will start after acute toxicity assessment of the first three patients of each cohort.
Dose and intervals for the trial consist of the following active groups: a) first cohort: 1 million cells/kg administered at days 1, 8 and 15; b) second cohort: 2 million cells / kg administered at days 1, 8 and 15; c) third cohort: 4 million cells / kg administered at days 1, 8 and 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Genetic: Stem cells1. first cohort: 1 million stem cells/kg administered at days 1, 8 and 15 2. second cohort: 2 million stem cells / kg administered at days 1, 8 and 15 3. third cohort: 4 million stem cells / kg administered at days 1, 8 and 15 |
| Placebo | Placebo comparator | Genetic: PlaceboLactate Ringer´s solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Must understand and voluntarily sign an informed consent form prior to the conduct of any study related assessment/procedures.
- Subjects with RA under treatment with at least one non-biologic-DMARD and failure to treatment with at least two biologics.
- Of either gender, aged ≥ 18 years at time of consent.
- Able to adhere to the study visit schedule and other protocol requirements.
- Have a diagnosis of RA for ≥6 months.
Key exclusion criteria (51 listed)
- Treatment with biologics within the following period prior to the start of treatment:
- Presence of a severe bleeding or thrombotic disorder.
- History of known pulmonary embolism or known secondary anti-phospholipid syndrome.
- Received any of the following treatments within 2 years prior to study entry: anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies for malignancy).
- Received within 4 weeks prior to the start of treatment: intra-articular, intramuscular or intravenous corticosteroids. (See also section 7.5).
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 |
|---|---|---|
| Stem cells1. first cohort: 1 million stem cells/kg administered at days 1, 8 and 15 2. second cohort: 2 million stem cells / kg administered at days 1, 8 and 15 3. third cohort: 4 million stem cells / kg administered at days 1, 8 and 15 | Genetic | Treatment |
| Placebo1. first cohort: 20 ml administered at days 1, 8 and 15 2. second cohort: 40 ml administered at days 1, 8 and 15 3. third cohort: 80 ml administered at days 1, 8 and 15 | Genetic | Placebo |
Primary outcome
Number of Adverse Events and Severe Adverse Events
Time frame: 6 months follow up after the first administration
Total number of Adverse Events and Severe Adverse Events, related and non-related with the medication will be recorded as a measure of tolerability and safety.
1 secondary outcome
Proportion of ACR20 patients/ACR50 patients/ACR70 patients (swollen joints*, tender joints, physician global assessment*, patient global assessment*, patient´s assessment of pain *, ESR/CRP, HAQ score)
Time frame: At selection and screening visit, and once per month during 6 months after the last administration
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 12 Apr 2019.
- Derived from this study: PubMed 27269294Alvaro-Gracia JM, Jover JA, Garcia-Vicuna R, Carreno L, Alonso A, Marsal S, Blanco F, Martinez-Taboada VM, Taylor P, Martin-Martin C, DelaRosa O, Tagarro I, Diaz-Gonzalez F. Intravenous administration of expanded allogeneic adipose-derived mesenchymal stem cells in refractory rheumatoid arthritis (Cx611): results of a multicentre, dose escalation, randomised, single-blind, placebo-controlled phase Ib/IIa clinical trial. Ann Rheum Dis. 2017 Jan;76(1):196-202. doi: 10.1136/annrheumdis-2015-208918. Epub 2016 Jun 7.
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.
José María Alvaro-Gracia, MD, PhD study chair
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
23 sites 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 Stem cells in people with Rheumatoid Arthritis Aggravated, run by Tigenix S.A.U. at 23 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 15 inclusion and 51 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. Some participants in this study may receive a placebo. 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?
Number of Adverse Events and Severe Adverse Events (time frame: 6 months follow up after the first administration). 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 NCT01663116, 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 12 Apr 2019.