CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT02647762|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2016
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: CF101 1 mg Drug: CF101 2 mg Drug: Placebo Drug: MTX||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||525 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||October 30, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: CF101 1mg
CF101 1mg, orally q12 hours
Drug: CF101 1 mg
CF101 tablets, 1mg BID for 12 weeks
Experimental: CF101 2mg
CF101 2mg, orally q12 hours
Drug: CF101 2 mg
CF101 tablets, 2 mg BID for 12 weeks
Active Comparator: MTX once weekly
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.
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.
Placebo Comparator: Placebo
Placebo control , orally q12 hours
Placebo tablets, 1mg BID for 12 weeks
- 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 ]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
- Assess the adverse event profile of daily oral CF101 under the conditions of the trial [ Time Frame: 24 weeks ]Nature, incidence and severity of treatment-emergent adverse events (TEAEs)
- Describe the pharmacokinetics (PK) of CF101 under the conditions of the trial [ Time Frame: 24 weeks ]Plasma CF101 levels will be determined
- 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 [ Time Frame: 24 weeks ]Change and percent change from baseline in DAS28
- Explore the relationship between whole blood adenosine A3 receptor (A3AR) expression and treatment response [ Time Frame: 24 weeks ]A3AR expression will be assessed on whole blood samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647762
|Study Director:||Michael H Silverman, MD||Can-Fite BioPharma|