Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (ACCORD-RA)

August 4, 2017 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Sanofi-Aventis Administrative Office
  • Croatia
      • Zagreb, Croatia
        • Sanofi-Aventis Administrative Office
  • Czechia
      • Praha, Czechia
        • Sanofi-Aventis Administrative Office
  • Romania
      • Bucuresti, Romania
        • Sanofi-Aventis Administrative Office
  • Russian Federation
      • Moscow, Russian Federation
        • Sanofi-Aventis Administrative Office
  • Slovakia
      • Bratislava, Slovakia
        • Sanofi-Aventis Administrative Office
  • Ukraine
      • Kiev, Ukraine
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSR150106 QD
90 micro grams oral solution once daily (QD)
Drug: SSR150106
Experimental: SSR150106 OEQD
90 micro grams oral solution once every other day (OEQD)
Drug: SSR150106
Placebo Comparator: Placebo
oral solution QD or OEQD
Drug: Placebos

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Karel PAVELKA, Prof., MD, Karel PAVELKA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT5488
  • EudraCT 2007-00760-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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