NCT00280917

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
7 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
8 years until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed
Last Updated

September 18, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

January 23, 2006

Results QC Date

February 24, 2015

Last Update Submit

August 28, 2023

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisRA

Outcome Measures

Primary Outcomes (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

    12 weeks

Secondary Outcomes (2)

  • ACR Criteria Components

    12 weeks

  • Safety

    12 weeks

Interventions

CF101DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Can-Fite Investigational Site

Peoria, Arizona, 85381, United States

Location

Can-Fite Investigational Site

Albany, New York, 12206, United States

Location

Can-Fite Invesitigational Site

Cleveland, Ohio, 44195, United States

Location

Can-Fite Investigational Site

Perrysburg, Ohio, 43551, United States

Location

Can-Fite Investigational Site

Sugar Land, Texas, 77479, United States

Location

Can-Fite Investigational Site

Plovdiv, 4002, Bulgaria

Location

Can-Fite Investigational Site

Sofia, 1233, Bulgaria

Location

Can-Fite Investigational Site

Sofia, 1612, Bulgaria

Location

Can-Fite Investigational Site

Stara Zagora, 6000, Bulgaria

Location

Can-Fite Investigational Sites

Afula, Israel

Location

Can-Fite Investigational Site

Ashkelon, 78278, Israel

Location

Can-Fite Investigational Site

Beer Yaakov, 70300, Israel

Location

Can-Fite Investigational Site

Haifa, 31096, Israel

Location

Can-Fite Investigational Site

Haifa, 77479, Israel

Location

Can-Fite Investigational Site

Jerusalem, 91031, Israel

Location

Can-Fite Investigational Site

Jerusalem, 91120, Israel

Location

Can-Fite Investigational Site

Jerusalem, Israel

Location

Can-Fite Investigational Site

Kfar Saba, 44281, Israel

Location

Can-Fite Investigational Site

Tel Litwinsky, 52621, Israel

Location

Can-Fite Investigational Site

Bialystok, 15-297, Poland

Location

Can-Fite Investigational Site

Lublin, 20-022, Poland

Location

Can-Fite Investigational Site

Sopot, 81-759, Poland

Location

Can-Fite Investigational Site

Szczecin, 71-252, Poland

Location

Can-Fite Investigational Site

Brasov, 500356, Romania

Location

Can-Fite Investigational Site

Bucharest, 020125, Romania

Location

Can-Fite Investigational Site

Bucharest, 020983, Romania

Location

Can-Fite Investigational Site

Cluj-Napoca, 400006, Romania

Location

Can-Fite Investigational Site

Iași, 700661, Romania

Location

Can-Fite Investigational Site

Belgrade, 11000, Serbia

Location

Can-Fite Investigational Site

Niška Banja, 18205, Serbia

Location

Can-Fite Investigational Site

Zemun, 11080, Serbia

Location

Can-Fite Investigational Site

Kiev, 01023, Ukraine

Location

Can-Fite Investigational Site

Kiev, 01103, Ukraine

Location

Can-Fite Investigational Site

Kiev, 03680, Ukraine

Location

Can-Fite Investigational Site

Kiev, 04053, Ukraine

Location

Related Publications (2)

  • 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.

    PMID: 9786512BACKGROUND

  • 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.

    PMID: 15742438BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

CF101

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Pnina Fishman, PhD
Organization
Can-Fite Biopharma
pnina@canfite.co.il
011972 39241114

Study Officials

  • Michael H Silverman, MD

    BioStrategics Consulting Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 24, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

September 18, 2023

Results First Posted

March 17, 2015

Record last verified: 2023-08

Locations

UA(4)BU(4)PL(4)RO(5)SE(3)US(5)IL(10)