Rheumatoid ArthritisPhase 2ACCORD-RANCT00545454
Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis
A Phase 2 study testing SSR150106 in people with Rheumatoid Arthritis, run by Sanofi at 7 sites in 7 countries.
Trial summary
The primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP). The secondary objectives are: to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SSR150106
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Oct 2007to Jun 2008
- 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
- Either treatment-naïve patients, or those who have discontinued their Rheumatoid Arthritis-directed medication due to intolerability or insufficient efficacy
- At least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min
- C-Reactive Protein >=1.8 mg/dl confirmed during screening period
- Non-poor Cytochrome P2D6 metabolizer status
Who cannot join
- Functional Rheumatoid Arthritis class IV
- Fever
- Infections with hepatitis B, or C, or HIV
- Presence or history (<5 years) of cancer
- Manifest or latent tuberculosis
- Functional abnormalities (including laboratory values) judged as clinically relevant
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (RA): A 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of 90 µg Administered Once Daily and 90 µg Once Every Other Day
The primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP).
The secondary objectives are:
- to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American College of Rheumatology response rate, and morning stiffness duration;
- to assess the effect on pain relief within first 14 days;
- to obtain evidence of the safety and tolerability of SSR150106;
- to document trough plasma levels of SSR150106 and its first metabolite.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SSR150106, Placebos
- Keywords
- Inflammation, anti-cytokine, anti-chemokine
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSR150106Drug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| SSR150106 QD | Experimental | 90 micro grams oral solution once daily (QD) Receives: Drug: SSR150106 |
| SSR150106 OEQD | Experimental | 90 micro grams oral solution once every other day (OEQD) Receives: Drug: SSR150106 |
| Placebo | Placebo comparator | oral solution QD or OEQD Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean C-Reactive Protein level
Measured: end of the 4-week double-blind treatment period
Secondary outcomes (5)
C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels
Measured: at all time points measured
Improvement responder rates based on the American College of Rheumatology criteria
Measured: at all time points measured
Pain relief (change from baseline)
Measured: until day 14
Safety and tolerability
Measured: During the entire study patient's participation
Plasma levels of SSR150106 and its first metabolite
Measured: On a weekly basis during treatment phase, except at the end of the 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karel PAVELKA, Prof., MD, Principal investigator, Karel PAVELKA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545454
- Sponsor's protocol ID
- ACT5488
- Other IDs
- EudraCT 2007-00760-24
- Acronym
- ACCORD-RA
- Status last verified
- Aug 2017
- First submitted
- 16 Oct 2007
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (RA): A 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of 90 µg Administered Once Daily and 90 µg Once Every Other Day
- ClinicalTrials.gov ID
- NCT00545454
- Acronym / sponsor ID
- ACCORD-RA / ACT5488
- Conditions
- Rheumatoid Arthritis
- Keywords
- Inflammation, anti-cytokine, anti-chemokine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Oct 2007 (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 primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP).
The secondary objectives are:
- to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American College of Rheumatology response rate, and morning stiffness duration;
- to assess the effect on pain relief within first 14 days;
- to obtain evidence of the safety and tolerability of SSR150106;
- to document trough plasma levels of SSR150106 and its first metabolite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SSR150106 QD | Experimental | Drug: SSR15010690 micro grams oral solution once daily (QD) |
| SSR150106 OEQD | Experimental | Drug: SSR15010690 micro grams oral solution once every other day (OEQD) |
| Placebo | Placebo comparator | Drug: Placebosoral solution QD or OEQD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Either treatment-naïve patients, or those who have discontinued their Rheumatoid Arthritis-directed medication due to intolerability or insufficient efficacy
- At least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min
- C-Reactive Protein >=1.8 mg/dl confirmed during screening period
- Non-poor Cytochrome P2D6 metabolizer status
Key exclusion criteria (7 listed)
- Functional Rheumatoid Arthritis class IV
- Fever
- Infections with hepatitis B, or C, or HIV
- Presence or history (<5 years) of cancer
- Manifest or latent tuberculosis
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 |
|---|---|---|
| SSR150106 | Drug | SSR150106 OEQD, SSR150106 QD |
| Placebos | Drug | Placebo |
Primary outcome
Change from baseline in mean C-Reactive Protein level
Time frame: end of the 4-week double-blind treatment period
5 secondary outcomes
C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels
Time frame: at all time points measured
Improvement responder rates based on the American College of Rheumatology criteria
Time frame: at all time points measured
Pain relief (change from baseline)
Time frame: until day 14
Safety and tolerability
Time frame: During the entire study patient's participation
Plasma levels of SSR150106 and its first metabolite
Time frame: On a weekly basis during treatment phase, except at the end of the 3rd week
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 8 Aug 2017.
- Related InfoLink provided by the sponsor.
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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.
Karel PAVELKA, Prof., MD principal investigator
Karel PAVELKA
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSR150106 in people with Rheumatoid Arthritis, run by Sanofi at 7 sites in 7 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 4 inclusion and 7 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Bulgaria, Croatia, Czechia, Romania, Russia and 2 more countries. 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?
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?
Change from baseline in mean C-Reactive Protein level (time frame: end of the 4-week double-blind treatment period). 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 8 Aug 2017.