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Rheumatoid ArthritisPhase 2NCT01034306

Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

A Phase 2 study testing CF101 in people with Rheumatoid Arthritis, run by Can-Fite BioPharma at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
CF101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
79 participants
Where
5 sitesin 2 countries
Study dates
Oct 2010to Dec 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Bulgaria4 sites

  • Multiprofile Hospital for Active Treatment

    Sofia, 1359

  • Diagnostic Consultative Center Sofia

    Sofia, 1505

  • Military Medical Academy

    Sofia, 1606

  • UMHAT "Sveti Ivan Rilski", Rheumatoloty Clinic

    Sofia, 1612

Other trials in Bulgaria

Israel1 site

  • Barzilai Medical Center

    Ashkelon

Other trials in Israel

About this study

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

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.

Read the 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.

Being tested
CF101, Placebo control
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CF101Drug

    Also called IB-MECA

    orally q12h

  • Placebo controlDrug

    Also called Inactive pill

    orally q12 hours

Study groups in NCT01034306
Study groupRoleWhat they receive
CF101 1 mgExperimentalpiclidenoson (CF101) 1 mg tablet oral, Q12h for 12 weeks
Receives: Drug: CF101
PlaceboPlacebo comparatorplacebo tablet to match the active, oral dosage, Q12h for 12 weeks
Receives: Drug: Placebo control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    1. >20% improvement in tender joint count (TJC), and
    2. >20% improvement in swollen joint count (SJC), and
    3. >20% improvement in at least 3 of following 5:
    4. Physician global assessment (PGA),
    5. Patient global assessment (PAGA),
    6. Patient pain assessment (PPA),
    7. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
    8. Most improved response of ESR and CRP

    Measured: 12 weeks

Secondary outcomes (2)

  1. Number of Subjects Achieving an ACR50 Response (50% Improvement)

    ACR50 Response is defined as a 50% improvement from baseline in disease:

    1. >50% improvement in TJC, and
    2. >50% improvement in SJC, and
    3. >50% improvement in at least 3 of following 5:
    4. Physician global assessment (PGA),
    5. Patient global assessment (PAGA),
    6. Patient pain assessment (PPA),
    7. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
    8. Most improved response of ESR and CRP

    Measured: 12 weeks

  2. Number of Subjects Achieving an ACR70 Response (70% Improvement)

    ACR70 Response is defined as a 70% improvement from baseline in disease:

    1. >70% improvement in TJC, and
    2. >70% improvement in SJC, and
    3. >70% improvement in at least 3 of following 5:
    4. Physician global assessment (PGA),
    5. Patient global assessment (PAGA),
    6. Patient pain assessment (PPA),
    7. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and
    8. Most improved response of ESR and CRP

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2009 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01034306
Sponsor's protocol ID
CF101-204RA
Status last verified
Feb 2022
First submitted
16 Dec 2009
Last updated
24 May 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CF101 in people with Rheumatoid Arthritis, run by Can-Fite BioPharma at 5 sites in 2 countries.

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 12 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Bulgaria, Israel. 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 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?

Yes. Results are posted in the registry (first posted 9 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement) (time frame: 12 weeks). 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 NCT01034306.

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 24 May 2022.

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