Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ISIS CRP Rx or Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Male or female; age 18 to 75 years
- Active RA for at least 6 months
- Active disease defined by having equal to or greater than 6 swollen joints and 6 tender joints, based on a 28 joint count
- On stable doses and regimen of allowed RA medications
- Currently receiving at least 10 mg of methotrexate a week. Patients unable to tolerate doses greater than 10 mg may also be eligible for enrollment.
Exclusion Criteria:
- Diagnosis of Felty's syndrome, psoriatic arthritis, gout, or auto-immune rheumatic disease
- Any surgical procedure within 30 days of Screening or likely to need joint or tendon surgery or other surgical procedure during the study
- Intra-articular or intra-muscular corticosteroids within 60 days prior to dosing
- Previous treatment with any biologic response modifying agent for RA within 90 days or 5 half-lives, whichever is greater, prior to screening
- Previous treatment with rituximab at any time
- Use of corticosteroid therapy equivalent to an average daily dose of >10 mg of prednisone
- Any Screening laboratory values that are out of allowed reference ranges
- Inability to comply with protocol or study procedures
- Any other significant illness or condition that may adversely affect the subjects participation in the study
Sites / Locations
- Isis Investigational site
- Isis Investigational Site
- Isis Investigational Site
- Isis Investigational Site
- Isis Investigational Site
- Isis Investigational Site
- Isis Investigational Site
- Isis Investigational Site
- Isis Investigational Site
- Isis Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Arm Description
Dose 1 ISIS CRP Rx versus Placebo
Dose 2 ISIS CRP Rx versus Placebo
Dose 3 ISIS CRP Rx versus Placebo
Outcomes
Primary Outcome Measures
Safety
Adverse events, laboratory tests, and vital signs
Secondary Outcome Measures
hsCRP
The effects of treatment with ISIS CRP Rx or Placebo on hsCRP
Full Information
NCT ID
NCT01414101
First Posted
July 21, 2011
Last Updated
May 16, 2013
Sponsor
Ionis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01414101
Brief Title
Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 329993 in Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ISIS CRP Rx and its effects on CRP and other pharmacodynamic measures, versus placebo, in subjects with active rheumatoid arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Dose 1 ISIS CRP Rx versus Placebo
Arm Title
Group B
Arm Type
Experimental
Arm Description
Dose 2 ISIS CRP Rx versus Placebo
Arm Title
Group C
Arm Type
Experimental
Arm Description
Dose 3 ISIS CRP Rx versus Placebo
Intervention Type
Drug
Intervention Name(s)
ISIS CRP Rx or Placebo
Primary Outcome Measure Information:
Title
Safety
Description
Adverse events, laboratory tests, and vital signs
Time Frame
155 Days
Secondary Outcome Measure Information:
Title
hsCRP
Description
The effects of treatment with ISIS CRP Rx or Placebo on hsCRP
Time Frame
155 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female; age 18 to 75 years
Active RA for at least 6 months
Active disease defined by having equal to or greater than 6 swollen joints and 6 tender joints, based on a 28 joint count
On stable doses and regimen of allowed RA medications
Currently receiving at least 10 mg of methotrexate a week. Patients unable to tolerate doses greater than 10 mg may also be eligible for enrollment.
Exclusion Criteria:
Diagnosis of Felty's syndrome, psoriatic arthritis, gout, or auto-immune rheumatic disease
Any surgical procedure within 30 days of Screening or likely to need joint or tendon surgery or other surgical procedure during the study
Intra-articular or intra-muscular corticosteroids within 60 days prior to dosing
Previous treatment with any biologic response modifying agent for RA within 90 days or 5 half-lives, whichever is greater, prior to screening
Previous treatment with rituximab at any time
Use of corticosteroid therapy equivalent to an average daily dose of >10 mg of prednisone
Any Screening laboratory values that are out of allowed reference ranges
Inability to comply with protocol or study procedures
Any other significant illness or condition that may adversely affect the subjects participation in the study
Facility Information:
Facility Name
Isis Investigational site
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C1K7
Country
Canada
Facility Name
Isis Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9L 3A2
Country
Canada
Facility Name
Isis Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
2RV1V6
Country
Canada
Facility Name
Isis Investigational Site
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Isis Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Isis Investigational Site
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
Isis Investigational Site
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Isis Investigational Site
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Isis Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Isis Investigational Site
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
25885521
Citation
Warren MS, Hughes SG, Singleton W, Yamashita M, Genovese MC. Results of a proof of concept, double-blind, randomized trial of a second generation antisense oligonucleotide targeting high-sensitivity C-reactive protein (hs-CRP) in rheumatoid arthritis. Arthritis Res Ther. 2015 Mar 19;17(1):80. doi: 10.1186/s13075-015-0578-5.
Results Reference
derived
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Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis
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