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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00545454

Acronym

ACCORD-RA

Enrollment

Registered

2007-10-17

Start date

2007-10-31

Completion date

2008-06-30

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Inflammation, anti-cytokine, anti-chemokine

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.

Interventions

DRUGSSR150106

DRUGPlacebos

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Bulgaria, Croatia, Czechia, Romania, Russia, Slovakia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026