Phase 2 N=79 Randomized Quadruple-blind Treatment

Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT01034306 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Mar 2015

Primary outcome: Primary: Number of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement) — 18; 8 Participants — p=0.0352

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CF101 (Drug); Placebo control (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Can-Fite BioPharma
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement)	18; 8	0.0352 sig
SECONDARY Number of Subjects Achieving an ACR50 Response (50% Improvement)	7; 3	.2472
SECONDARY Number of Subjects Achieving an ACR70 Response (70% Improvement)	4; 1	0.1972

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.

Eligibility Criteria

Inclusion Criteria

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
If taking an oral corticosteroid, dose is 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01034306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.