Clinical trial NCT00545454: Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Inflammation
anti-cytokine
anti-chemokine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in mean C-Reactive Protein level
timeFrame: end of the 4-week double-blind treatment period
Secondary outcomes:
measure: C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels
timeFrame: at all time points measured
measure: Improvement responder rates based on the American College of Rheumatology criteria
timeFrame: at all time points measured
measure: Pain relief (change from baseline)
timeFrame: until day 14
measure: Safety and tolerability
timeFrame: During the entire study patient's participation
measure: Plasma levels of SSR150106 and its first metabolite
timeFrame: On a weekly basis during treatment phase, except at the end of the 3rd week
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Sanofi-Aventis Administrative Office
city: Zagreb
country: Croatia
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czechia
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Bratislava
country: Slovakia
facility: Sanofi-Aventis Administrative Office
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Karel PAVELKA
name: Karel PAVELKA, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: