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Rheumatoid ArthritisPhase 2NCT00556894

Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

A Phase 2 study testing CF101 in people with Rheumatoid Arthritis, run by Can-Fite BioPharma at 26 sites in 6 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 addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months. 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
253 participants
Where
26 sitesin 6 countries
Study dates
Feb 2008to Apr 2009
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; refer to Appendix 1. diagnostic criteria for Rheumatoid Arthritis)
  • 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
  • Treatment with weekly oral or parenteral methotrexate for >=6 months prior to baseline
  • Methotrexate route of administration has been unchanged for >=2 months prior to baseline
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  • Dose of methotrexate has been stable at 15-25 mg/week for >=2 months, and is expected to remain stable throughout the study; the stable dose of methotrexate may alternatively be 10-12.5 mg/week if documented toxicity has precluded a higher dose
  • If taking hydroxychloroquine or chloroquine, administration duration has been for >=3 months and dose has been stable for >=2 months prior to baseline
  • If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to baseline, 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 stabilization period, and will remain stable through the stabilization and entire treatment and follow-up period
  • 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)

Who cannot join

  • Receipt of any of the following for at least a 1 month stabilization period prior to dosing: sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
  • Receipt of etanercept for at least a 6 week period prior to dosing
  • Receipt of cyclosporine, infliximab or adalimumab for at least a 2 month period prior to dosing
  • Receipt of leflunomide for at least a 2 month period prior to screening, unless patient has undergone cholestyramine washout at least 1 month prior to dosing
  • Receipt of cyclophosphamide for at least a 6 month period prior to dosing
  • Receipt of rituximab at any previous time
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  • 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 dosing
  • Change in oral corticosteroid dose level during the 1 month prior to, or during, the stabilization period vChange in hydroxychloroquine or chloroquine dose level during the 2 months prior to, or during, the stabilization period
  • Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to, or during, the stabilization period
  • Significant cardiac arrhythmia or conduction block, congestive heart failure, or any other evidence of clinically significant heart disease; other clinically significant findings on screening electrocardiogram (ECG)
  • Hemoglobin level <9.0 gm/dL at the screening visit
  • Platelet count <125,000/mm3 at the screening visit
  • White blood cell count <3000/mm3 at the screening visit
  • Serum creatinine level outside the central laboratory's normal limits at the screening visit
  • Liver aminotransferase (ALT and/or AST) levels greater than 1.25 times the central laboratory's upper limit of normal at the screening visit
  • Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study

Trial locations and contacts

26 sites in 6 countries.

26 sites in 6 countries

Ukraine6 sites

  • Central Municipal Clinical Hospital nº1

    Donetsk, 83114

  • Kyiv Central Municipal Hospital

    Kiev, 01023

  • City Clinical Hospital N12

    Kiev, 01103

  • National Scientific Centre of AMS of Ukraine

    Kiev, 03680

  • O.O. Bogomolets National Medical University

    Kiev, 04053

  • Vinnitsya Regional Clinical Hospital

    Vinnycia, 21018

Other trials in Ukraine

Bulgaria5 sites

  • Clinic of Rheumatology at MHAT 'Sveti Georgi'

    Plovdiv, 4002

  • Clinic of Rheumatology at MHAT 'Sveti Ivan Rilski'

    Sofia, 1612

  • Clinic of internal diseases at NMTH 'Tzar Boris Treti'

    Sofia

  • Second Clinic of Internal Diseases at MHAT 'Stara Zagora'

    Stara Zagora, 6000

  • Clinic of Rheumatology at MHAT 'Sveta Marina' - Varna

    Varna, 9010

Other trials in Bulgaria

Israel5 sites

  • Haemek Medical Center

    Afula

  • Barzilai Medical Center

    Ashkelon, 78278

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah Har-Hazofim Medical Center

    Jerusalem

  • Meir Medical Center

    Kfar Saba, 44281

Other trials in Israel

Poland5 sites

  • Wojewodzki Szpital Zespolony w Elblagu

    Elblag, 82300

  • Niepubliczny Zaklad Opieki Zdrowotnej

    Lublin, 20607

  • Wojewodzki Zespol Reumatologiczny w Sopocie

    Sopot, 81967

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 P.A.M. w Szczecinie

    Szczecin, 71252

  • Niepubliczny Zaklad Opieki Zdrowotnej "NASZ LEKARZ"

    Torun, 87100

Other trials in Poland

Czechia3 sites

  • University Hospital Hradec Kralove

    Hradec Králové, 50005

  • Institute of Rheumatology

    Prague, 12850

  • Rheumotology Out-patient Clinic

    Zlín, 76001

Other trials in Czechia

Serbia2 sites

  • Institute of Rheumatology - Belgrade

    Belgrade, 11000

  • Institute for Prevention, Treatment, and Rehabilitation of Rheumatoid and Cardiovascular Diseases Niska Banja

    Niška Banja, 18205

Other trials in Serbia

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis

This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months.

Read the detailed description

This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for >=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 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) (with the exception of hydroxychloroquine), 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
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

  • PlaceboDrug

    orally q12h

Study groups in NCT00556894
Study groupRoleWhat they receive
CF101 0.1 mgExperimentalCF101 0.1 mg was given orally q12h
Receives: Drug: CF101
CF101 1 mgExperimentalCF101 1 mg was given orally q12h
Receives: Drug: CF101
PlaceboPlacebo comparatorMatched placebo was given orally q12h
Receives: Drug: Placebo

What is being measured

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

  1. ACR20 at Week 12

    Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria

    Measured: 12 weeks

Secondary outcomes (1)

  1. ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters

    ACR20/50/70 responses over time (intent-to-treat [ITT], last observation carried forward [LOCF]), mean changes in individual components of the ACR response criteria, DAS28, European League Against Rheumatism (EULAR) responses

    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 posted12 Nov 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionMar 2009
  4. Study completionApr 2009

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00556894
Sponsor's protocol ID
CF101-203RA
Status last verified
Aug 2011
First submitted
8 Nov 2007
Last updated
29 Mar 2018
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 26 sites in 6 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 12 inclusion and 18 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Ukraine, Bulgaria, Israel, Poland, Czechia and 1 more country. 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?

ACR20 at Week 12 (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 NCT00556894.

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 29 Mar 2018.

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