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Completed

NCT Number: NCT00545454

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Inflammation Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSR150106

Drug

Placebos

Drug

Primary outcomes

  1. Change from baseline in mean C-Reactive Protein level

    Time frame: end of the 4-week double-blind treatment period

Secondary outcomes

  1. C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels

    Time frame: at all time points measured

  2. Improvement responder rates based on the American College of Rheumatology criteria

    Time frame: at all time points measured

  3. Pain relief (change from baseline)

    Time frame: until day 14

  4. Safety and tolerability

    Time frame: During the entire study patient's participation

  5. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: ACCORD-RA

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 17, 2007
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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