Rheumatoid ArthritisPhase 2NCT01414101
Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis
A Phase 2 study of Rheumatoid Arthritis, run by Ionis Pharmaceuticals, Inc. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Aug 2011to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Russia7 sites
Isis Investigational Site
Moscow, 109240
Isis Investigational Site
Moscow, 115522
Isis Investigational Site
Moscow, 121374
Isis Investigational Site
Saint Petersburg, 191104
Isis Investigational Site
Saint Petersburg, 196247
Isis Investigational Site
Saint Petersburg, 197022
Isis Investigational Site
Saint Petersburg, 199106
Canada3 sites
Isis Investigational site
Kamloops, British Columbia, V2C1K7
Isis Investigational Site
Montreal, Quebec, 2RV1V6
Isis Investigational Site
Toronto, Ontario, M9L 3A2
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ISIS CRP Rx or Placebo
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS CRP Rx or PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dose 1 ISIS CRP Rx versus Placebo Receives: Drug: ISIS CRP Rx or Placebo |
| Group B | Experimental | Dose 2 ISIS CRP Rx versus Placebo Receives: Drug: ISIS CRP Rx or Placebo |
| Group C | Experimental | Dose 3 ISIS CRP Rx versus Placebo Receives: Drug: ISIS CRP Rx or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse events, laboratory tests, and vital signs
Measured: 155 Days
Secondary outcomes (1)
hsCRP
The effects of treatment with ISIS CRP Rx or Placebo on hsCRP
Measured: 155 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414101
- Sponsor's protocol ID
- ISIS 329993-CS3
- Status last verified
- May 2013
- First submitted
- 21 Jul 2011
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25885521
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01414101
- Acronym / sponsor ID
- ISIS 329993-CS3
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: ISIS CRP Rx or PlaceboDose 1 ISIS CRP Rx versus Placebo |
| Group B | Experimental | Drug: ISIS CRP Rx or PlaceboDose 2 ISIS CRP Rx versus Placebo |
| Group C | Experimental | Drug: ISIS CRP Rx or PlaceboDose 3 ISIS CRP Rx versus Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISIS CRP Rx or Placebo | Drug | Group A, Group B, Group C |
Primary outcome
Safety
Time frame: 155 Days
Adverse events, laboratory tests, and vital signs
1 secondary outcome
hsCRP
Time frame: 155 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
- Derived from this study: PubMed 25885521Warren 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.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Rheumatoid Arthritis, run by Ionis Pharmaceuticals, Inc. at 10 sites in 2 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 5 inclusion and 9 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 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Russia, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: 155 Days). 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 NCT01414101, which also lists 1 linked publication.
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 17 May 2013.