Status:
COMPLETED
Bovine Intestinal Alkaline Phosphatase (bIAP) Modulating Rheumatoid Arthritis
Lead Sponsor:
Alloksys Life Sciences B.V.
Collaborating Sponsors:
Aix Scientifics
Conditions:
Acute Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01416493
Start Date
May 1 2011
End Date
April 1 2013
Last Update
March 10 2015
Active Locations (1)
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1
Maidstone Hospital, Dept. Rheumatology
Maidstone, Kent, United Kingdom, ME16 9QQ