Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00545454
• Date of registration: 16/10/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis ACCORD-RA
• Scientific 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
• Date of first enrolment: October 2007
• Target sample size: 79
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00545454
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Croatia, Czech Republic, Czechia, Former Serbia and Montenegro, Romania, Russian Federation, Slovakia, Ukraine

Contacts

• Name: Karel PAVELKA, Prof., MD
• Affiliation: Karel PAVELKA

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebos

Drug: SSR150106

Primary Outcome(s)

Change from baseline in mean C-Reactive Protein level [Time Frame: end of the 4-week double-blind treatment period]

Secondary Outcome(s)

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]

C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels [Time Frame: at all time points measured]

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]

Safety and tolerability [Time Frame: During the entire study patient's participation]

Secondary ID(s)

ACT5488

EudraCT 2007-00760-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors