Rheumatoid ArthritisPhase 1AutoDECRANCT01352858
Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis (AutoDECRA)
A Phase 1 study testing TolDC and Arthroscopy & saline irrigation alone in people with Rheumatoid Arthritis, run by Newcastle University at 1 site in United Kingdom.
Trial summary
This is a study which will look at safety, feasibility and acceptability of a new therapy called tolerogenic dendritic cells (TolDC), derived from the patient's own white blood cells, which will be injected into the knee joints of rheumatoid arthritis patients, using a procedure called arthroscopy (a camera… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TolDC and Arthroscopy & saline irrigation alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give informed consent and to comply with the study protocol
- At least 6 month's disease duration
- ACR Functional Class I-III
- Age 18 years or over
- Active disease, including an inflamed (native) knee joint
- Failure (or intolerance of) at least one disease modifying anti-rheumatic drug (DMARD), including current therapy
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- Morning stiffness in the target joint ≥ 30 minutes
- Willing and able to undergo arthroscopic procedures under local anaesthetic
- Stable dose of non-steroidal anti-inflammatory drug (NSAID) or corticosteroid (prednisolone≤10mg) for ≥4 weeks
- No intramuscular glucocorticoid administration for ≥ 6 weeks
- Stable dose of disease-modifying anti-rheumatic drug (DMARD) for ≥8 weeks
Who cannot join
- Use of other investigational medicinal products within 30 days prior to study entry (defined as date of recruitment into study)
- Patients who have received rituximab therapy and whose B-cell count remains below the normal range. Patients who have received any other cell depleting therapies and whose cell counts have not returned to the normal range, at the discretion of the principal investigator.
- Serious or unstable co-morbidity deemed unsuitable by PI, eg. COPD, cardiac failure
- History of malignancy (except treated basal cell carcinoma of skin)
- Known active infection at screening visit or at baseline (except fungal nail infection)
- Infection requiring hospitalization or IV antibiotics within 6 weeks of baseline
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- Immunization with live vaccine within 6 weeks of baseline
- History of recurrent or chronic infection
- History of hepatitis B or C, syphilis, HIV or HTLV-1/2 infections
- Injection of target joint with glucocorticoids within 6 weeks of baseline
- Hb<10g/dL; neutrophils< 2.00 x109/L; platelets <150x109/L; ALT/ALP>2x upper limit of normal; elevated serum creatinine at screening visit.
- Major surgery within 8 weeks of baseline or planned within 3 months from baseline
- Pregnancy, or women planning to become pregnant within the study period, or women who are breast feeding
- Females or males of child bearing potential unwilling to use adequate contraception for duration of study
- Patients taking anticoagulants
- Known hypersensitivity to local or systemic corticosteroid therapy or local anaesthetic.
- Poor venous access or medical condition precluding leukapheresis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis
This is a study which will look at safety, feasibility and acceptability of a new therapy called tolerogenic dendritic cells (TolDC), derived from the patient's own white blood cells, which will be injected into the knee joints of rheumatoid arthritis patients, using a procedure called arthroscopy (a camera examination of a joint). The investigators are also looking to see if the drug has any effect on the disease activity (if it can help in RA) and whether the drug can affect the immune system. The investigators aim to treat 12 patients in total, 9 with TolDC and 3 with a control treatment. Three doses of TolDC will be tested, 3 patients per dose. Subjects will have RA and at least one swollen knee joint. They will undergo a knee ultrasound scan, fill in a series of questionnaires, have their knee aspirated (fluid taken out) and finally undergo a procedure called leukapheresis (removal of white blood cells) from which the treatment will be manufactured. Subsequently they will undergo 3 arthroscopies (camera examination of the knee joint) over a period of about 12 weeks. On the first arthroscopy they will have the TolDC injected into their knee joint. They will then spend the night at the Clinical Research facility for observation. Over the next 5 days they will be telephoned daily by the study doctor to check how they are, and will be reassessed if needed. About 2 weeks later they will have their second arthroscopy to look for effects of treatment, and the third will take place at 13 weeks (end of study) or sooner if the knee appears to get worse.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TolDC, Arthroscopy & saline irrigation alone
- Keywords
- Arthritis, RA, Auto-immune disorders
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolDCDrug
Tolerogenic dendritic cells (TolDC), derived ex vivo from autologous monocytes, administered arthroscopically into an inflamed knee following saline irrigation.
Arthroscopy & saline irrigation aloneDrug
| Study group | Role | What they receive |
|---|---|---|
| TolDC | Experimental | Experimental arm - TolDC administered arthroscopically Receives: Drug: TolDC |
| Control | Placebo comparator | Arthroscopy \& saline irrigation alone Receives: Drug: Arthroscopy & saline irrigation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients experiencing AEs and SAEs following the intra-articular administration of TolDC.
Measured: within 3 months of injection
Secondary outcomes (4)
• The proportion of RA patients who enter the study, from whom GMP-grade TolDC of sufficient quality can be prepared (the success rate of the TolDC preparation procedure).
Measured: Within one week of donation of blood for extraction of TolDC
• The proportion of patients who grade the trial and its related procedures as acceptable.
Trial participants will assess acceptability of study specific procedures via an 'acceptability questionnaire' administered at the last study visit
Measured: At final study visit, 3 months after study intervention.
Systemic RA disease activity
Disease Activity Score using 28 joints (DAS28)
Measured: At baseline and at 7, 14 and 91 days post intervention
Knee function
Function will be assessed using the Health Assessment Questionnaire (HAQ), a standard instrument used in RA
Measured: At baseline and at 7, 14 and 91 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startFeb 2012
- Primary completionNov 2018
- Study completionNov 2018
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK, Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352858
- Sponsor's protocol ID
- AutoDECRA 1.0
- Acronym
- AutoDECRA
- Status last verified
- Nov 2023
- First submitted
- 11 May 2011
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bell GM, Anderson AE, Diboll J, Reece R, Eltherington O, Harry RA, Fouweather T, MacDonald C, Chadwick T, McColl E, Dunn J, Dickinson AM, Hilkens CM, Isaacs JD. Autologous tolerogenic dendritic cells for rheumatoid and inflammatory arthritis. Ann Rheum Dis. 2017 Jan;76(1):227-234. doi: 10.1136/annrheumdis-2015-208456. Epub 2016 Apr 26.
PubMed 27117700
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01352858
- Acronym / sponsor ID
- AutoDECRA / AutoDECRA 1.0
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis, RA, Auto-immune disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Arthritis Research UK, Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- Feb 2012
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 12 May 2011 (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.
This is a study which will look at safety, feasibility and acceptability of a new therapy called tolerogenic dendritic cells (TolDC), derived from the patient's own white blood cells, which will be injected into the knee joints of rheumatoid arthritis patients, using a procedure called arthroscopy (a camera examination of a joint). The investigators are also looking to see if the drug has any effect on the disease activity (if it can help in RA) and whether the drug can affect the immune system. The investigators aim to treat 12 patients in total, 9 with TolDC and 3 with a control treatment. Three doses of TolDC will be tested, 3 patients per dose. Subjects will have RA and at least one swollen knee joint. They will undergo a knee ultrasound scan, fill in a series of questionnaires, have their knee aspirated (fluid taken out) and finally undergo a procedure called leukapheresis (removal of white blood cells) from which the treatment will be manufactured. Subsequently they will undergo 3 arthroscopies (camera examination of the knee joint) over a period of about 12 weeks. On the first arthroscopy they will have the TolDC injected into their knee joint. They will then spend the night at the Clinical Research facility for observation. Over the next 5 days they will be telephoned daily by the study doctor to check how they are, and will be reassessed if needed. About 2 weeks later they will have their second arthroscopy to look for effects of treatment, and the third will take place at 13 weeks (end of study) or sooner if the knee appears to get worse.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TolDC | Experimental | Drug: TolDCExperimental arm - TolDC administered arthroscopically |
| Control | Placebo comparator | Drug: Arthroscopy & saline irrigation aloneArthroscopy \& saline irrigation alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able and willing to give informed consent and to comply with the study protocol
- At least 6 month's disease duration
- ACR Functional Class I-III
- Age 18 years or over
- Active disease, including an inflamed (native) knee joint
Key exclusion criteria (17 listed)
- Use of other investigational medicinal products within 30 days prior to study entry (defined as date of recruitment into study)
- Patients who have received rituximab therapy and whose B-cell count remains below the normal range. Patients who have received any other cell depleting therapies and whose cell counts have not returned to the normal range, at the discretion of the principal investigator.
- Serious or unstable co-morbidity deemed unsuitable by PI, eg. COPD, cardiac failure
- History of malignancy (except treated basal cell carcinoma of skin)
- Known active infection at screening visit or at baseline (except fungal nail infection)
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 |
|---|---|---|
| TolDCTolerogenic dendritic cells (TolDC), derived ex vivo from autologous monocytes, administered arthroscopically into an inflamed knee following saline irrigation. | Drug | TolDC |
| Arthroscopy & saline irrigation alone | Drug | Control |
Primary outcome
The proportion of patients experiencing AEs and SAEs following the intra-articular administration of TolDC.
Time frame: within 3 months of injection
4 secondary outcomes
• The proportion of RA patients who enter the study, from whom GMP-grade TolDC of sufficient quality can be prepared (the success rate of the TolDC preparation procedure).
Time frame: Within one week of donation of blood for extraction of TolDC
• The proportion of patients who grade the trial and its related procedures as acceptable.
Time frame: At final study visit, 3 months after study intervention.
Systemic RA disease activity
Time frame: At baseline and at 7, 14 and 91 days post intervention
Knee function
Time frame: At baseline and at 7, 14 and 91 days post-intervention
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 30 Nov 2023.
- Derived from this study: PubMed 27117700Bell GM, Anderson AE, Diboll J, Reece R, Eltherington O, Harry RA, Fouweather T, MacDonald C, Chadwick T, McColl E, Dunn J, Dickinson AM, Hilkens CM, Isaacs JD. Autologous tolerogenic dendritic cells for rheumatoid and inflammatory arthritis. Ann Rheum Dis. 2017 Jan;76(1):227-234. doi: 10.1136/annrheumdis-2015-208456. Epub 2016 Apr 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TolDC and Arthroscopy & saline irrigation alone in people with Rheumatoid Arthritis, run by Newcastle University at 1 site in United Kingdom.
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 11 inclusion and 17 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 30 Nov 2023. 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 United Kingdom. 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 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?
The proportion of patients experiencing AEs and SAEs following the intra-articular administration of TolDC. (time frame: within 3 months of injection). 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 NCT01352858, 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 30 Nov 2023.