Back to resultsOral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CF101
Placebo control
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Males and females ages 18-75 years
- Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al. Arthritis Rheum 1988;31:315-324, Appendix 1)
- Not bed- or wheelchair-bound
- Active RA, as indicated by the presence of (a) >=6 swollen joints (28 joint count); AND (b) >=6 tender joints (28 joint count); AND either: (c) Westergren ESR of >=28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory
- Elevated PBMC A3AR expression level, defined as >= 1.5-fold over a predetermined normal population standard, following the appropriate DMARD/biologic washout period (see Exclusion Criteria) but within 2 weeks of beginning dosing
- If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during protocol participation
- If taking an oral corticosteroid, dose is <=10 mg/day prednisone or equivalent, has been stable for at least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during protocol participation
- In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
- Negative screening serum pregnancy test for female patients of childbearing potential
- Females of childbearing potential must utilize, throughout the course of the trial, 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method)
- All aspects of the protocol explained and written informed consent obtained
Exclusion Criteria:
- Receipt of any of the following for at least a 1 month washout period prior to the A3AR Qualification Visit: methotrexate, sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
- Receipt of etanercept for at least a 6 week washout period prior to the A3AR Qualification Visit
- Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab or adalimumab for at least a 2 month washout period prior to the A3AR Qualification Visit
- Receipt of leflunomide for at least a 2 month washout period prior to the A3AR Qualification Visit, unless patient has undergone cholestyramine washout at least 1 month prior to testing
- Receipt of cyclophosphamide for at least a 6 month period prior to the A3AR Qualification Visit
- Receipt of rituximab at any previous time
- Previous failure to respond to methotrexate or any anti-rheumatic biological agent
- Participation in a previous trial CF101 trial
- Use of oral corticosteroids >10 mg of prednisone, or equivalent, per day
- Change in NSAID dose level for 1 month prior to the A3AR Qualification Visit
- Change in oral corticosteroid dose level during the 1 month prior to the A3AR Qualification Visit
- Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the A3AR Qualification Visit
Sites / Locations
- Multiprofile Hospital for Active Treatment
- Diagnostic Consultative Center Sofia
- Military Medical Academy
- UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic
- Barzilai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CF101 1 mg
Placebo
Arm Description
piclidenoson (CF101) 1 mg tablet oral, Q12h for 12 weeks
placebo tablet to match the active, oral dosage, Q12h for 12 weeks
Outcomes
Primary Outcome Measures
Number of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement)
ACR20 Response is defined as a 20% improvement from baseline in disease:
>20% improvement in tender joint count (TJC), and
>20% improvement in swollen joint count (SJC), and
>20% improvement in at least 3 of following 5:
Physician global assessment (PGA),
Patient global assessment (PAGA),
Patient pain assessment (PPA),
Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
Most improved response of ESR and CRP
Secondary Outcome Measures
Number of Subjects Achieving an ACR50 Response (50% Improvement)
ACR50 Response is defined as a 50% improvement from baseline in disease:
>50% improvement in TJC, and
>50% improvement in SJC, and
>50% improvement in at least 3 of following 5:
Physician global assessment (PGA),
Patient global assessment (PAGA),
Patient pain assessment (PPA),
Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
Most improved response of ESR and CRP
Number of Subjects Achieving an ACR70 Response (70% Improvement)
ACR70 Response is defined as a 70% improvement from baseline in disease:
>70% improvement in TJC, and
>70% improvement in SJC, and
>70% improvement in at least 3 of following 5:
Physician global assessment (PGA),
Patient global assessment (PAGA),
Patient pain assessment (PPA),
Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
Most improved response of ESR and CRP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01034306
Brief Title
Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis
Official Title
A Phase IIB Study of the Efficacy and Safety of Daily CF101 in Patients With Active Rheumatoid Arthritis and Elevated Baseline Expression Levels of Peripheral Blood Mononuclear Cell A3 Adenosine Receptors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Can-Fite BioPharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at baseline will relieve signs and symptoms of the disease.
Detailed Description
This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, study in which patients with active RA and high A3AR expression at baseline will be randomized to the addition of either CF101 1.0 mg or placebo given orally q12h for 12 weeks. Screening examinations will occur within 1 month prior to dosing. Washout of other disease-modifying antirheumatic drugs (DMARDs), including biological agents, will occur prior to dosing; if washout is necessary, patients must re-qualify for inclusion following the washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids must be stable for >=1 month prior to dosing and remain so during protocol participation. Disease activity will be assessed using swollen and tender joint counts, physician and patient global assessments (by visual analog scale, VAS), patient reported pain (by VAS), a Health Assessment Questionnaire (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP) levels. Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, and 12.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CF101 1 mg
Arm Type
Experimental
Arm Description
piclidenoson (CF101) 1 mg tablet oral, Q12h for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablet to match the active, oral dosage, Q12h for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CF101
Other Intervention Name(s)
IB-MECA
Intervention Description
orally q12h
Intervention Type
Drug
Intervention Name(s)
Placebo control
Other Intervention Name(s)
Inactive pill
Intervention Description
orally q12 hours
Primary Outcome Measure Information:
Title
Number of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement)
Description
ACR20 Response is defined as a 20% improvement from baseline in disease:
>20% improvement in tender joint count (TJC), and
>20% improvement in swollen joint count (SJC), and
>20% improvement in at least 3 of following 5:
Physician global assessment (PGA),
Patient global assessment (PAGA),
Patient pain assessment (PPA),
Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
Most improved response of ESR and CRP
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving an ACR50 Response (50% Improvement)
Description
ACR50 Response is defined as a 50% improvement from baseline in disease:
>50% improvement in TJC, and
>50% improvement in SJC, and
>50% improvement in at least 3 of following 5:
Physician global assessment (PGA),
Patient global assessment (PAGA),
Patient pain assessment (PPA),
Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
Most improved response of ESR and CRP
Time Frame
12 weeks
Title
Number of Subjects Achieving an ACR70 Response (70% Improvement)
Description
ACR70 Response is defined as a 70% improvement from baseline in disease:
>70% improvement in TJC, and
>70% improvement in SJC, and
>70% improvement in at least 3 of following 5:
Physician global assessment (PGA),
Patient global assessment (PAGA),
Patient pain assessment (PPA),
Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
Most improved response of ESR and CRP
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ages 18-75 years
Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al. Arthritis Rheum 1988;31:315-324, Appendix 1)
Not bed- or wheelchair-bound
Active RA, as indicated by the presence of (a) >=6 swollen joints (28 joint count); AND (b) >=6 tender joints (28 joint count); AND either: (c) Westergren ESR of >=28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory
Elevated PBMC A3AR expression level, defined as >= 1.5-fold over a predetermined normal population standard, following the appropriate DMARD/biologic washout period (see Exclusion Criteria) but within 2 weeks of beginning dosing
If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during protocol participation
If taking an oral corticosteroid, dose is <=10 mg/day prednisone or equivalent, has been stable for at least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during protocol participation
In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
Negative screening serum pregnancy test for female patients of childbearing potential
Females of childbearing potential must utilize, throughout the course of the trial, 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method)
All aspects of the protocol explained and written informed consent obtained
Exclusion Criteria:
Receipt of any of the following for at least a 1 month washout period prior to the A3AR Qualification Visit: methotrexate, sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
Receipt of etanercept for at least a 6 week washout period prior to the A3AR Qualification Visit
Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab or adalimumab for at least a 2 month washout period prior to the A3AR Qualification Visit
Receipt of leflunomide for at least a 2 month washout period prior to the A3AR Qualification Visit, unless patient has undergone cholestyramine washout at least 1 month prior to testing
Receipt of cyclophosphamide for at least a 6 month period prior to the A3AR Qualification Visit
Receipt of rituximab at any previous time
Previous failure to respond to methotrexate or any anti-rheumatic biological agent
Participation in a previous trial CF101 trial
Use of oral corticosteroids >10 mg of prednisone, or equivalent, per day
Change in NSAID dose level for 1 month prior to the A3AR Qualification Visit
Change in oral corticosteroid dose level during the 1 month prior to the A3AR Qualification Visit
Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the A3AR Qualification Visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Silverman, MD
Organizational Affiliation
BioStrategics Consulting Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Multiprofile Hospital for Active Treatment
City
Sofia
ZIP/Postal Code
1359
Country
Bulgaria
Facility Name
Diagnostic Consultative Center Sofia
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
12. IPD Sharing Statement
Links:
URL
http://www.canfite.co.il
Description
Sponsor
Learn more about this trial
Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis
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