Acute Rheumatoid ArthritisPhase 1/2ALS-003-2008NCT01416493
Bovine Intestinal Alkaline Phosphatase (bIAP) Modulating Rheumatoid Arthritis
A Phase 1/2 study testing s.c. injections of bovine intestinal Alkaline Phosphatase in people with Acute Rheumatoid Arthritis, run by Alloksys Life Sciences B.V. at 1 site in United Kingdom.
Trial summary
This is a proof of concept study asking if alkaline phosphatase injections can reduce acute inflammation in rheumatoid arthritis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Rheumatoid Arthritis
- What is being tested?
- s.c. injections of bovine intestinal Alkaline Phosphatase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Apr 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
- 1. Male or non-pregnant, non-lactating female patients of any race with an age >18 years. Woman of child-bearing potential must be on regular contraceptives throughout the trial (Pregnancy tests).
- 1A: RA according to the 1987 revised ARA criteria (Arnett 1987) with an active disease with DAS28>3.2 despite the prior or concurrent use of DMARDs.
- 2. Patients may be on no active therapy or may be on continuous DMARD therapy including Methotrexate, Sulphasalazine, Leflunomide, Hydroxychloroquine, Myocrisin alone or in combination, or on NSAID treatment, or on steroid (prednisolone not more than 10mg/day).
- 3. Patients must have a measurable acute phase response: CRP (> 10mg/dl), ESR > 25. (to be measured on routine lab range CRP/ ESR/AP/ standard biochemistry)
- 4. Patients eligible for treatment with biological TNFα blockers and who are awaiting the administration of such treatment may enroll in the laboratory and safety protocols Data for Clinical Phase observations will be collected but will be handled as last observation carried forward for the final records prior to the administration of TNF blocking agent, should that occur within the 3-month Clinical Phase. The administration of TNFα blockers will not be delayed for the protocol.
- 5. Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.
Who cannot join
- Patients who are unwilling or unable to be fully evaluated for follow-up.
- Patients who have an active infection or who are suspected of having systemic infection and or patients that are treated with antibiotics.
- Patients whose screening blood do not reflect a sufficient cytokine or acute phase response.
- Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin > 34.2 umol/L (> 2.0 mg/dL), ALT (>120) or AST (>135) corresponding to > 3X upper limit of normal.
- Alkaline phosphatase levels must be less 145 IU/L (routine clinical method)
- Patients who received investigational drugs in the 30 days prior to study drug administration, or are currently participating in a study during which the administration of investigational drugs within one month is anticipated.
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- Patients who have renal insufficiency (history of creatinine >177umol/L or >2.0 mg/dL) or chronic renal failure requiring dialysis.
- Patients with severe neurological deficits (see Appendix I).
- Patients who have a recent history of drug substance or alcohol abuse.
- Patients with a diagnosis of idiopathic thrombocytopenia.
- Patients with a history of cancer who have received chemotherapy or radiation therapy within the past 3 months. Patients receiving only adjuvant hormonal therapy are not excluded. If the cancer has not resolved completely, the patient should not be enrolled without permission of Alloksys.
- Patients receiving oral glucocorticoids >10mg /day or any IV, IM or Intra articular dosing within 30 days of commencing the protocol.
- Patients who are vegetarians or veganists or those patients that may be expected not to be tolerant to bovine proteins, or not to wish exposure to bovine proteins for personal reasons.
- Patients who are, in the opinion of the Investigator or the Sponsor, unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Maidstone Hospital, Dept. Rheumatology
Maidstone, Kent, ME16 9QQ
About this study
Official title: An OPEN LABEL Phase II Safety Study of Bovine Intestinal Alkaline Phosphatase (bIAP), an Inflammation Modulating Moiety, in RA Patients
This is a proof of concept study asking if alkaline phosphatase injections can reduce acute inflammation in rheumatoid arthritis patients.
Read the detailed description
This is a proof of concept study to establish the safety of subcutaneous (sc) treatment and the efficacy of alkaline phosphatase (AP) in reducing specific pro-inflammatory cytokines during and after 3 days of twice daily s.c. treatment. A total dose of 12000 Units AP will be administered by 2000 IU s.c. injection twice daily for 3 days. Subjects will be closely followed for 8 days and regular clinical observations will be made during 3 months. Close out will be 3 months after initiation of treatment.
- Conditions
- Acute Rheumatoid Arthritis
- Being tested
- s.c. injections of bovine intestinal Alkaline Phosphatase
- Keywords
- acute rheumatoid arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
s.c. injections of bovine intestinal Alkaline PhosphataseDrug
daily subcutaneous treatment with two injections of 2000IU bIAP for three days
| Study group | Role | What they receive |
|---|---|---|
| bIAP treatment | Experimental | Not described Receives: Drug: s.c. injections of bovine intestinal Alkaline Phosphatase |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood level of the pro-inflammatory cytokines: TNFα and IL6
The anticipated effects of bIAP will be short lived, within 4 days. However, in order to capture durable clinical responses or any late adverse effects, patients will be followed through 3 months at weeks 2, 4, 8 and 12 incorporating trial observations with routine monthly care to reduce disruption to patients.
Measured: 3 months
Secondary outcomes (1)
RA clinical status expressed as Daily Activity Score (DAS-28)
van der Heijde DM, van 't Hof MA, van Riel PL, Theunisse LA, Lubberts EW, van Leeuwen MA, van Rijswijk MH, van de Putte LB. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Dis. 1990 Nov;49(11):916-920
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alloksys Life Sciences B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- Anthony Hammond, MD, Principal investigator, Maidstone Hospital, Dept. Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416493
- Sponsor's protocol ID
- REUMAP
- Other IDs
- 2008-007346-63, 2008
- Acronym
- ALS-003-2008
- Status last verified
- Mar 2015
- First submitted
- 11 Aug 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An OPEN LABEL Phase II Safety Study of Bovine Intestinal Alkaline Phosphatase (bIAP), an Inflammation Modulating Moiety, in RA Patients
- ClinicalTrials.gov ID
- NCT01416493
- Acronym / sponsor ID
- ALS-003-2008 / REUMAP
- Conditions
- Acute Rheumatoid Arthritis
- Keywords
- acute rheumatoid arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Alloksys Life Sciences B.V.Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Aug 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 proof of concept study asking if alkaline phosphatase injections can reduce acute inflammation in rheumatoid arthritis patients.
Detailed description
This is a proof of concept study to establish the safety of subcutaneous (sc) treatment and the efficacy of alkaline phosphatase (AP) in reducing specific pro-inflammatory cytokines during and after 3 days of twice daily s.c. treatment. A total dose of 12000 Units AP will be administered by 2000 IU s.c. injection twice daily for 3 days. Subjects will be closely followed for 8 days and regular clinical observations will be made during 3 months. Close out will be 3 months after initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bIAP treatment | Experimental | Drug: s.c. injections of bovine intestinal Alkaline Phosphatase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Male or non-pregnant, non-lactating female patients of any race with an age >18 years. Woman of child-bearing potential must be on regular contraceptives throughout the trial (Pregnancy tests).
- 1A: RA according to the 1987 revised ARA criteria (Arnett 1987) with an active disease with DAS28>3.2 despite the prior or concurrent use of DMARDs.
- 2. Patients may be on no active therapy or may be on continuous DMARD therapy including Methotrexate, Sulphasalazine, Leflunomide, Hydroxychloroquine, Myocrisin alone or in combination, or on NSAID treatment, or on steroid (prednisolone not more than 10mg/day).
- 3. Patients must have a measurable acute phase response: CRP (> 10mg/dl), ESR > 25. (to be measured on routine lab range CRP/ ESR/AP/ standard biochemistry)
- 4. Patients eligible for treatment with biological TNFα blockers and who are awaiting the administration of such treatment may enroll in the laboratory and safety protocols Data for Clinical Phase observations will be collected but will be handled as last observation carried forward for the final records prior to the administration of TNF blocking agent, should that occur within the 3-month Clinical Phase. The administration of TNFα blockers will not be delayed for the protocol.
Key exclusion criteria (14 listed)
- Patients who are unwilling or unable to be fully evaluated for follow-up.
- Patients who have an active infection or who are suspected of having systemic infection and or patients that are treated with antibiotics.
- Patients whose screening blood do not reflect a sufficient cytokine or acute phase response.
- Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin > 34.2 umol/L (> 2.0 mg/dL), ALT (>120) or AST (>135) corresponding to > 3X upper limit of normal.
- Alkaline phosphatase levels must be less 145 IU/L (routine clinical method)
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 |
|---|---|---|
| s.c. injections of bovine intestinal Alkaline Phosphatasedaily subcutaneous treatment with two injections of 2000IU bIAP for three days | Drug | bIAP treatment |
Primary outcome
blood level of the pro-inflammatory cytokines: TNFα and IL6
Time frame: 3 months
The anticipated effects of bIAP will be short lived, within 4 days. However, in order to capture durable clinical responses or any late adverse effects, patients will be followed through 3 months at weeks 2, 4, 8 and 12 incorporating trial observations with routine monthly care to reduce disruption to patients.
1 secondary outcome
RA clinical status expressed as Daily Activity Score (DAS-28)
Time frame: 3 months
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 10 Mar 2015.
- an other running study with bovine Intestinal Alkaline Phosphatase (bIAP)Link 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.
Anthony Hammond, MD principal investigator
Maidstone Hospital, Dept. Rheumatology
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 s.c. injections of bovine intestinal Alkaline Phosphatase in people with Acute Rheumatoid Arthritis, run by Alloksys Life Sciences B.V. 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 6 inclusion and 14 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 10 Mar 2015. 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. 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?
blood level of the pro-inflammatory cytokines: TNFα and IL6 (time frame: 3 months). 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 10 Mar 2015.