Recruitment

Recruitment Status
Completed

Inclusion Criterias

moderately to severely active RA, when the response to disease-modifying anti-rheumatic drugs, including methotrexate, is inadequate,and,severe, active and active RA in adults not previously treated with methotrexate.
Patients over the age of 18 years
Indication for adalimumab therapy, according to guidelines:
...
moderately to severely active RA, when the response to disease-modifying anti-rheumatic drugs, including methotrexate, is inadequate,and,severe, active and active RA in adults not previously treated with methotrexate.
Patients over the age of 18 years
Indication for adalimumab therapy, according to guidelines:
Patients with RA according to ACR 1987 criteria

Exclusion Criterias

History of cancer
Patients not having TB prophylaxis as per guidelines for latent TB, or patients non-treated active tuberculosis
Moderate to severe heart failure .
...
History of cancer
Patients not having TB prophylaxis as per guidelines for latent TB, or patients non-treated active tuberculosis
Moderate to severe heart failure .
Renal failure
History of demyelinising disease
Patients who have previously received anti-TNF therapy
History of cardiovascular or cerebrovascular disease
Patients with recurrent serious infections
Hypersensitivity to adalimumab or one of the excipients.
Any unstable medical condition
Absence of informed consent
Active tuberculosis or other severe infections such as sepsis and opportunistic infections
Minors, pregnant women, not adequate contraception if female with childbearing potential, majors under guardianship, residents of social welfare or health care establishments, patients presenting an emergency situation, patients not covered by French social security, subjects deprived of their freedom and patients refusing to participate in the clinical research.

Summary

Conditions
Rheumatoid Arthritis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

moderately to severely active RA, when the response to disease-modifying anti-rheumatic drugs, including methotrexate, is inadequate,and,severe, active and active RA in adults not previously treated with methotrexate.
Patients over the age of 18 years
Indication for adalimumab therapy, according to guidelines:
...
moderately to severely active RA, when the response to disease-modifying anti-rheumatic drugs, including methotrexate, is inadequate,and,severe, active and active RA in adults not previously treated with methotrexate.
Patients over the age of 18 years
Indication for adalimumab therapy, according to guidelines:
Patients with RA according to ACR 1987 criteria

Exclusion Criterias

History of cancer
Patients not having TB prophylaxis as per guidelines for latent TB, or patients non-treated active tuberculosis
Moderate to severe heart failure .
...
History of cancer
Patients not having TB prophylaxis as per guidelines for latent TB, or patients non-treated active tuberculosis
Moderate to severe heart failure .
Renal failure
History of demyelinising disease
Patients who have previously received anti-TNF therapy
History of cardiovascular or cerebrovascular disease
Patients with recurrent serious infections
Hypersensitivity to adalimumab or one of the excipients.
Any unstable medical condition
Absence of informed consent
Active tuberculosis or other severe infections such as sepsis and opportunistic infections
Minors, pregnant women, not adequate contraception if female with childbearing potential, majors under guardianship, residents of social welfare or health care establishments, patients presenting an emergency situation, patients not covered by French social security, subjects deprived of their freedom and patients refusing to participate in the clinical research.

Locations

Marseille
Marseille

Tracking Information

NCT #
NCT01954381
Collaborators
Not Provided
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille