Relapsing-remitting Multiple SclerosisPhase 2NCT01051817
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
A Phase 2 study testing AIN457 in people with Relapsing-remitting Multiple Sclerosis and RRMS, run by Novartis Pharmaceuticals at 16 sites in 3 countries.
Trial summary
A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis, RRMS
- What is being tested?
- AIN457
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Dec 2009to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Czechia6 sites
Novartis Investigative Site
Hradec Králové, Czech Republic, 500 05
Novartis Investigative Site
Ostrava
Novartis Investigative Site
Ostrava-Moravska Ostrava
Novartis Investigative Site
Prague, 128 08
Novartis Investigative Site
Prague
Novartis Investigative Site
Teplice, 415 29
Ukraine6 sites
Novartis Investigative Site
Kharkiv, 61068
Novartis Investigative Site
Kharkiv
Novartis Investigative Site
Kiev, 03110
Novartis Investigative Site
Kiev
Novartis Investigative Site
Odesa, 65025
Novartis Investigative Site
Vinnitsya, 21005
Russia4 sites
Novartis Investigative Site
Kazan', 420021
Novartis Investigative Site
Moscow, 129128
Novartis Investigative Site
Nizhny Novgorod, 603155
Novartis Investigative Site
Smolensk, 214019
About this study
Official title: A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis
A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis
- Conditions
- Relapsing-remitting Multiple Sclerosis, RRMS
- Being tested
- AIN457, Placebo
- Keywords
- relapsing-remitting multiple sclerosis, RRMS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457Drug
infusion 10 mg/Kg
PlaceboDrug
infusion
| Study group | Role | What they receive |
|---|---|---|
| AIN457 | Experimental | Not described Receives: Drug: AIN457 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.
Measured: weeks 4,8,12,16,20,24,28
Secondary outcomes (2)
Raw Number of Cumulative New Gd-T1 Lesions
The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24.
Measured: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
Raw Number of Cumulative New Gd-T2 Lesions
The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24.
Measured: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051817
- Sponsor's protocol ID
- CAIN457B2201
- Other IDs
- 2009-011626-34, 2009
- Status last verified
- Feb 2015
- First submitted
- 19 Jan 2010
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01051817
- Acronym / sponsor ID
- CAIN457B2201
- Conditions
- Relapsing-remitting Multiple Sclerosis, RRMS
- Keywords
- relapsing-remitting multiple sclerosis, RRMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Posted 27 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIN457 | Experimental | Drug: AIN457 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| AIN457infusion 10 mg/Kg | Drug | AIN457 |
| Placeboinfusion | Drug | Placebo |
Primary outcome
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Time frame: weeks 4,8,12,16,20,24,28
Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.
2 secondary outcomes
Raw Number of Cumulative New Gd-T1 Lesions
Time frame: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
Raw Number of Cumulative New Gd-T2 Lesions
Time frame: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AIN457 in people with Relapsing-remitting Multiple Sclerosis and RRMS, run by Novartis Pharmaceuticals at 16 sites in 3 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 1 inclusion and 1 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Czechia, Ukraine, Russia. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment (time frame: weeks 4,8,12,16,20,24,28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2015.