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Rheumatoid ArthritisPhase 2NCT00280917

Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

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

Completed

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

Official record
Search all trials

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
How many people
254 participants
Where
35 sitesin 7 countries
Study dates
Jun 2006to Apr 2007
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 Rheumatism Association 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 at least one of the following: (c) Westergren ESR of >=28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory; OR (e) morning stiffness for >=45 minutes
  • 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, administration duration has been >=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 washout period, and will remain stable through the washout and entire treatment and follow-up period
  • Absence of clinically significant findings, such as interstitial pneumonitis or active pulmonary infection, on chest X-ray taken within 6 months prior to screening

Who cannot join

  • Receipt of any of the following for at least a 1 month washout 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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  • Receipt of CF101 in a previous 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 washout period
  • Change in hydroxychloroquine dose level during the 2 months prior to, or during, the washout period
  • Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to, or during, the washout period
  • Presence or history of uncontrolled asthma
  • Presence or history of uncontrolled arterial hypertension or symptomatic hypotension
  • 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/L
  • Platelet count <125,000/mm3
  • White blood cell count <3000/mm3
  • Serum creatinine level outside the laboratory's normal limits
  • Liver aminotransferase levels greater than 1.2 times the 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

Trial locations and contacts

35 sites in 7 countries.

35 sites in 7 countries

Israel10 sites

  • Can-Fite Investigational Sites

    Afula

  • Can-Fite Investigational Site

    Ashkelon, 78278

  • Can-Fite Investigational Site

    Beer Yaakov, 70300

  • Can-Fite Investigational Site

    Haifa, 31096

  • Can-Fite Investigational Site

    Haifa, 77479

  • Can-Fite Investigational Site

    Jerusalem, 91031

  • Can-Fite Investigational Site

    Jerusalem, 91120

  • Can-Fite Investigational Site

    Jerusalem

  • Can-Fite Investigational Site

    Kfar Saba, 44281

  • Can-Fite Investigational Site

    Tel HaShomer, 52621

Other trials in Israel

United States5 sites

  • Can-Fite Investigational Site

    Albany, New York, 12206

  • Can-Fite Invesitigational Site

    Cleveland, Ohio, 44195

  • Can-Fite Investigational Site

    Peoria, Arizona, 85381

  • Can-Fite Investigational Site

    Perrysburg, Ohio, 43551

  • Can-Fite Investigational Site

    Sugar Land, Texas, 77479

Other trials in United States

Romania5 sites

  • Can-Fite Investigational Site

    Brasov, 500356

  • Can-Fite Investigational Site

    Bucharest, 020125

  • Can-Fite Investigational Site

    Bucharest, 020983

  • Can-Fite Investigational Site

    Cluj-Napoca, 400006

  • Can-Fite Investigational Site

    Iași, 700661

Other trials in Romania

Bulgaria4 sites

  • Can-Fite Investigational Site

    Plovdiv, 4002

  • Can-Fite Investigational Site

    Sofia, 1233

  • Can-Fite Investigational Site

    Sofia, 1612

  • Can-Fite Investigational Site

    Stara Zagora, 6000

Other trials in Bulgaria

Poland4 sites

  • Can-Fite Investigational Site

    Bialystok, 15-297

  • Can-Fite Investigational Site

    Lublin, 20-022

  • Can-Fite Investigational Site

    Sopot, 81-759

  • Can-Fite Investigational Site

    Szczecin, 71-252

Other trials in Poland

Ukraine4 sites

  • Can-Fite Investigational Site

    Kiev, 01023

  • Can-Fite Investigational Site

    Kiev, 01103

  • Can-Fite Investigational Site

    Kiev, 03680

  • Can-Fite Investigational Site

    Kiev, 04053

Other trials in Ukraine

Serbia3 sites

  • Can-Fite Investigational Site

    Belgrade, 11000

  • Can-Fite Investigational Site

    Niška Banja, 18205

  • Can-Fite Investigational Site

    Zemun, 11080

Other trials in Serbia

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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, CF101 4 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, duration of morning stiffness, 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, 12, and 14.

Being tested
CF101
Keywords
Rheumatoid Arthritis, RA
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

What is being measured

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

  1. ACR Efficacy Criteria

    ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population

    Measured: 12 weeks

Secondary outcomes (2)

  1. ACR Criteria Components

    ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components [tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR], Disease Activity Score (DAS28), and duration of morning stiffness.

    Measured: 12 weeks

  2. Safety

    Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs

    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 posted24 Jan 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionApr 2007
  4. Study completionApr 2007

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
Not applicable
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00280917
Sponsor's protocol ID
CF101-202RA
Status last verified
Aug 2023
First submitted
23 Jan 2006
Last updated
18 Sep 2023

Publications

  • Szabo C, Scott GS, Virag L, Egnaczyk G, Salzman AL, Shanley TP, Hasko G. Suppression of macrophage inflammatory protein (MIP)-1alpha production and collagen-induced arthritis by adenosine receptor agonists. Br J Pharmacol. 1998 Sep;125(2):379-87. doi: 10.1038/sj.bjp.0702040.

    PubMed 9786512

  • Baharav E, Bar-Yehuda S, Madi L, Silberman D, Rath-Wolfson L, Halpren M, Ochaion A, Weinberger A, Fishman P. Antiinflammatory effect of A3 adenosine receptor agonists in murine autoimmune arthritis models. J Rheumatol. 2005 Mar;32(3):469-76.

    PubMed 15742438

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 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: finished, as of the sponsor's last update on 18 Sep 2023. 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 Israel, United States, Romania, Bulgaria, 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. 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 17 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?

ACR Efficacy Criteria (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 NCT00280917, which also lists 2 linked publications.

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 18 Sep 2023.

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