Brief 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 (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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline

Completed

Started Oct 2007

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

October 1, 2007

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed

Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

October 16, 2007

Last Update Submit

August 4, 2017

Conditions

Rheumatoid Arthritis

Keywords

Inflammationanti-cytokineanti-chemokine

Outcome Measures

Primary Outcomes (1)

Change from baseline in mean C-Reactive Protein level
end of the 4-week double-blind treatment period

Secondary Outcomes (5)

C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels
at all time points measured
Improvement responder rates based on the American College of Rheumatology criteria
at all time points measured
Pain relief (change from baseline)
until day 14
Safety and tolerability
During the entire study patient's participation
Plasma levels of SSR150106 and its first metabolite
On a weekly basis during treatment phase, except at the end of the 3rd week

Study Arms (3)

SSR150106 QD

EXPERIMENTAL

90 micro grams oral solution once daily (QD)

Drug: SSR150106

SSR150106 OEQD

EXPERIMENTAL

90 micro grams oral solution once every other day (OEQD)

Drug: SSR150106

Placebo

PLACEBO COMPARATOR

oral solution QD or OEQD

Drug: Placebos

Interventions

SSR150106DRUG

SSR150106 OEQDSSR150106 QD

PlacebosDRUG

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.