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Rheumatoid ArthritisPhase 3NCT02647762

CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis

A Phase 3 study testing CF101 1 mg, CF101 2 mg and MTX in people with Rheumatoid Arthritis, run by Can-Fite BioPharma at 35 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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 will relieve signs and symptoms of the disease. CF101 effect will be in comparison to MTX in this study population. 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 1 mg, CF101 2 mg and MTX
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
244 participants
Where
35 sitesin 7 countries
Study dates
30 Oct 2017to 30 Nov 2020
Phase
Phase 3
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 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 EULAR Disease Activity Score (Fransen, vanRiel, 2005, DAS28, 2015) (DAS28) >3.2.
  • Demonstrate at least 6 swollen and at least 6 tender joints.
  • If taking an NSAID, dose has been stable for at least 1 month prior to the Screening 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 Screening 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 subjects 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

  • Prior receipt of MTX.
  • Prior receipt of >1 regimen of synthetic small-molecule DMARDs.
  • Receipt of any non-MTX synthetic small-molecule DMARDs (including but not limited to sulfasalazine, chloroquine/hydroxychloroquine, azathioprine, and/or leflunomide) for at least 1 month prior to the Screening Visit or concomitantly during the trial.
  • Receipt of tofacitinib at any time during the 4-week period prior to the Screening Visit or concomitantly during the trial.
  • Receipt of a biologic anti-rheumatic agent (including, but not limited to, etanercept, abatacept, infliximab, golimumab, adalimumab, tocilizumab, certolizumab, and rituximab) at any time prior to or concomitantly during the trial.
  • Levels of rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibody that are both >3 times the upper limit of the laboratory normal value at the Screening Visit.
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  • Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the Screening Visit.
  • Participation in a previous trial CF101 trial.
  • Presence or history of uncontrolled arterial hypertension or symptomatic hypotension.
  • Heart disease which is, in the Investigator's judgment, clinically significant or unstable, including coronary artery disease, congestive heart failure, uncontrolled arrhythmia, or other significant findings on Screening electrocardiogram (ECG).
  • Clinical laboratory abnormalities at the Screening Visit as follows:
  • Hemoglobin level <9.0 gm/dL
  • Platelet count <125,000/mm3
  • White blood cell (WBC) count <3000/mm3
  • Serum creatinine level outside the central laboratory's normal limits
  • Liver aminotransferase (ALT and/or AST) levels greater than 2 times the central laboratory's upper limit of normal.
  • Known or suspected immunodeficiency or human immunodeficiency virus positivity.
  • Pregnancy, lactation, or inadequate contraception as judged by the Investigator.
  • Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening.
  • Active drug or alcohol dependence.
  • History of malignancy within the past 2 years (excluding excised basal or squamous cell carcinoma of the skin).
  • Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

Trial locations and contacts

35 sites in 7 countries.

35 sites in 7 countries

Romania12 sites

  • Can-Fite Investigational Site #559

    Brăila

  • Can-Fite Investigational Site #551

    Bucharest

  • Can-Fite Investigational Site #552

    Bucharest

  • Can-Fite Investigational Site #553

    Bucharest

  • Can-Fite Investigational Site #562

    Bucharest

  • Can-Fite Investigational Site #564

    Bucharest

  • Can-Fite Investigational Site #565

    Bucharest

  • Can-Fite Investigational Site #558

    Constanța

  • Can-Fite Investigational Site #563

    Craiova

  • Can-Fite Investigational Site #561

    Iași

  • Can-Fite Investigational Site #555

    Oradea

  • Can-Fite Investigational Site #554

    Timișoara

Other trials in Romania

Serbia9 sites

  • Can-Fite Investigational Site #212

    Belgrade

  • Can-Fite Investigational Site #223

    Bor

  • Can-Fite Investigational Site #219

    Kragujevac

  • Can-Fite Investigational Site #215

    Niš

  • Can-Fite Investigational Site #213

    Novi Sad

  • Can-Fite Investigational Site #222

    Pirot

  • Can-Fite Investigational Site #214

    Šabac

  • Can-FIte Investigational Site #221

    Sremska Mitrovica

  • Can-Fite Investigational Site #220

    Zrenjanin

Other trials in Serbia

Bosnia and Herzegovina5 sites

  • Can-Fite Investigational Site #252

    Banja Luka

  • Can-Fite Investigational Site #256

    Banja Luka

  • Can-Fite Investigational Site #253

    Mostar

  • Can-Fite Investigational Site #251

    Sarajevo

  • Can-Fite Investigational Site #255

    Tuzla

Other trials in Bosnia and Herzegovina

Moldova3 sites

  • Can-Fite Investigational Site #581

    Chisinau

  • Can-Fite Investigational Site #582

    Chisinau

  • Can-Fite Investigational Site #583

    Chisinau

Other trials in Moldova

Poland3 sites

  • Can-Fite Investigational Site #401

    Bialystok

  • Can-Fite Investigational Site #402

    Bochnia

  • Can-Fite Investigational Site #403

    Poznan

Other trials in Poland

Israel2 sites

  • Can-Fite Investigational Site #309

    Ashkelon

  • Can-Fite Investigational Site #302

    Haifa

Other trials in Israel

Canada1 site

  • Can-Fite Investigational Site #751

    Barrie

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis

This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with rheumatoid arthritis will relieve signs and symptoms of the disease. CF101 effect will be in comparison to MTX in this study population.

Read the detailed description

This will be a randomized, double-blind, active- and placebo-controlled, parallel-group study in subjects with clinically active RA but who are MTX-naïve. Subjects who meet enrollment criteria will be randomized to 1 of 4 groups in a 2:2:2:1 ratio: CF101 1 mg, CF101 2 mg, MTX, or matching placebo tablets. CF101 or matching placebo will be administered every 12 hours for up to 24 weeks on treatment. MTX or matching placebo will be administered once a week Screening examinations will occur within 6 weeks prior to dosing. The following conventional drugs for RA treatment must be stable for the respective designated periods prior to the Screening Visit and must remain so during protocol participation: nonsteroidal anti-inflammatory drugs (NSAIDS), and corticosteroids for >1 month. All subjects will receive oral folate (minimum dose 5 mg/week) or oral folinic acid (up to 10 mg/week), based on the Investigator's preference.

Disease activity will be assessed using swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and CRP. Efficacy will be assessed by Disease Activity Score 28 using the erythrocyte sedimentation rate (DAS28-ESR), ACR response criteria and European League Against Rheumatism (EULAR) response criteria : swollen and tender joint counts, physician global assessment (by visual analog scale, patient global assessment , patient reported pain, a Health Assessment Questionnaire (HAQ) Disability Index (DI) , Westergren ESR levels, and CRP levels. Assessments will occur at Screening, Baseline (Week 0), and Weeks 4, 8, 12 16, 20, and 24. At Weeks 12, 16, and 20, any subject who has not experienced at least 20% improvement in both the number of swollen and number of tender joints will be given rescue therapy with open-label oral MTX and followed through Week 24.

PK will be assessed in a subgroup of approximately 100 subjects at Week 0, Week 8, and Week 12. All subjects in the PK cohort will have samples collected for PK at time 0, and each subject will have additional samples drawn at 2 of the following post-dose time points: 1, 2, 3, 4, 6, and 8 hours. Whole blood sample for A3AR expression will be assessed in approximately 100 subjects at selected sites at Screening and Week 12, or end of dosing, if occurring before Week 12.

Being tested
CF101 1 mg, CF101 2 mg, Placebo, MTX
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • CF101 1 mgDrug

    Also called IB-MECA, Piclidenosone

    CF101 tablets, 1mg BID for 12 weeks

  • CF101 2 mgDrug

    Also called IB-MECA, Piclidenosone

    CF101 tablets, 2 mg BID for 12 weeks

  • PlaceboDrug

    Placebo tablets, 1mg BID for 12 weeks

  • MTXDrug

    MTX 5 mg tablets, given once weekly at 10 mg/week (2 tablets) for the first 2 weeks, then 15 mg/week (3 tablets) for the next 2 weeks, then 20 mg/week (4 tablets) thereafter, for 12 weeks.

Study groups in NCT02647762
Study groupRoleWhat they receive
CF101 1mgExperimentalCF101 1mg, orally q12 hours
Receives: Drug: CF101 1 mg
CF101 2mgExperimentalCF101 2mg, orally q12 hours
Receives: Drug: CF101 2 mg
MTX once weeklyActive comparatorMTX 5 mg tablets, given once weekly at 10 mg/week (2 tablets) for the first 2 weeks, then 15 mg/week (3 tablets) for the next 2 weeks, then 20 mg/week (4 tablets) thereafter.
Receives: Drug: MTX
PlaceboPlacebo comparatorPlacebo control , orally q12 hours
Receives: Drug: Placebo

What is being measured

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

  1. Efficacy of oral CF101, BID for 12 weeks to subjects with active rheumatoid arthritis (RA) relative to oral methotrexate (MTX) as assessed by the proportion of subjects achieving a Disease Activity Score (DAS) of Low Disease Activity (LDA)

    Proportion of subjects achieving Disease Activity Score (DAS) (based on Erythrocyte Sedimentation Rate) of Low Disease Activity (<3.2, where lower scores indicate lower disease activity) at Week 12

    Measured: 12 weeks

  2. Assess the adverse event profile of daily oral CF101 under the conditions of the trial

    Nature, incidence and severity of treatment-emergent adverse events (TEAEs)

    Measured: 24 weeks

  3. Describe the pharmacokinetics (PK) of CF101 under the conditions of the trial

    Plasma CF101 levels will be determined

    Measured: 24 weeks

Secondary outcomes (2)

  1. Determine the efficacy of oral CF101 when administered daily for 24 weeks to subjects with active RA relative to oral MTX, as assessed by the proportion of subjects achieving DAS remission

    Change and percent change from baseline in DAS28

    Measured: 24 weeks

  2. Explore the relationship between whole blood adenosine A3 receptor (A3AR) expression and treatment response

    A3AR expression will be assessed on whole blood samples

    Measured: 24 weeks

Timeline

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

  1. First posted6 Jan 2016 (estimated)
  2. Study start30 Oct 2017
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Why it stopped: Interim analysis results

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02647762
Sponsor's protocol ID
CF101-301RA
Status last verified
Mar 2020
First submitted
16 Dec 2015
Last updated
19 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CF101 1 mg, CF101 2 mg and MTX in people with Rheumatoid Arthritis, run by Can-Fite BioPharma at 35 sites in 7 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 22 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: stopped early, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Romania, Serbia, Bosnia and Herzegovina, Moldova, Poland and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Interim analysis results). Results are not available in the source record.

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?

Efficacy of oral CF101, BID for 12 weeks to subjects with active rheumatoid arthritis (RA) relative to oral methotrexate (MTX) as assessed by the proportion of subjects achieving a Disease Activity Score (DAS) of Low Disease Activity (LDA) (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT02647762.

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 19 Dec 2020.

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