Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study.

Conditions

rheumatoid arthritis (RA)

Brief summary

Level of RA activity according to Disease Activity score on 28 joints (DAS28).

Detailed description

Proportion of patients who reach remission after 6, 12 and 24 months of treatment (DAS < 2,6)., Proportion of patients with low disease activity after 6 months of treatment (DAS < 3,2)., Proportion of patients for which a biologic treatment is introduced after 6, 12 and 24 months of treatment., Description of some metabolic parameters within the two groups of treatment: weight loss, waist circumference, fasting glycemia and hemoglobin A1c level (HbA1c), cholesterol levels, triglycerids, insulinemia, and bilirubin., Proportion of patients who present a serious adverse event within the two groups during the 6 months of treatment., Description of the evolution of functional assessment according to Health Assessment Questionnaire (HAQ) within the two groups during the 6 months of treatment.

Related papers

No related papers found yet.

Interventions

DRUGFOLIC ACID

DRUGPL1

DRUGMETFORMINE ARROW LAB 500 mg

DRUGcomprimé pelliculé

DRUGMETHOTREXATE

DRUGPREDNISONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Level of RA activity according to Disease Activity score on 28 joints (DAS28).	—

Secondary

Measure	Time frame
Proportion of patients who reach remission after 6, 12 and 24 months of treatment (DAS < 2,6)., Proportion of patients with low disease activity after 6 months of treatment (DAS < 3,2)., Proportion of patients for which a biologic treatment is introduced after 6, 12 and 24 months of treatment., Description of some metabolic parameters within the two groups of treatment: weight loss, waist circumference, fasting glycemia and hemoglobin A1c level (HbA1c), cholesterol levels, triglycerids, insulinemia, and bilirubin., Proportion of patients who present a serious adverse event within the two groups during the 6 months of treatment., Description of the evolution of functional assessment according to Health Assessment Questionnaire (HAQ) within the two groups during the 6 months of treatment.	—

Measure

Time frame

Proportion of patients who reach remission after 6, 12 and 24 months of treatment (DAS < 2,6)., Proportion of patients with low disease activity after 6 months of treatment (DAS < 3,2)., Proportion of patients for which a biologic treatment is introduced after 6, 12 and 24 months of treatment., Description of some metabolic parameters within the two groups of treatment: weight loss, waist circumference, fasting glycemia and hemoglobin A1c level (HbA1c), cholesterol levels, triglycerids, insulinemia, and bilirubin., Proportion of patients who present a serious adverse event within the two groups during the 6 months of treatment., Description of the evolution of functional assessment according to Health Assessment Questionnaire (HAQ) within the two groups during the 6 months of treatment.

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Countries

France

Outcome results

None listed