Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

P. Verschueren400 enrolled

Overview

The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study introduced the principle of fast remission induction by means of a combination of standard Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose glucocorticoids in early Rheumatoid Arthritis. The purpose of the present study is to compare different combinations of traditional DMARDs and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid Arthritis. Besides the efficacy and effectiveness of these strategies, patient centered outcomes and potential implementation problems of such treatment strategies are evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Rheumatoid Arthritis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of RA as defined by the 1987 or 2010 revised American College of Rheumatology (ACR) criteria * Early RA (less than 1 year) * Use a reliable method of contraception for women of childbearing potential * Able and willing to give written informed consent and participate in the study Exclusion Criteria: * Previous treatment with DMARDs * Previous treatment with oral corticosteroids at a dosage of more than 10 milligrams (mg) prednisone within 4 weeks before baseline * Previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg prednisone within 2 weeks before baseline * Previous treatment with oral corticosteroids for more than 4 weeks * Previous treatment with Intra Articular corticosteroids within 4 weeks before baseline * Previous treatment with an investigational drug for the treatment or prevention of RA * Contraindications for corticosteroids * Contraindications for DMARDs * Psoriatic Arthritis * Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study * Pregnancy, breastfeeding or no use of a reliable method of contraception * Alcohol or drug abuse

Locations (17)

ASZ

Aalst, Belgium

OLV Ziekenhuis

Aalst, Belgium

Imelda Ziekenhuis

Bonheiden, Belgium

AZ St Lucas

Bruges, Belgium

Reuma praktijk

Genk, Belgium

Reumacentrum

Genk, Belgium

UZ Gent, dept. of Rheumatology

Ghent, Belgium

Reuma instituut Hasselt

Hasselt, Belgium

Reumapraktijk

Hasselt, Belgium

Jan Yperman Ziekenhuis

Ieper, Belgium

...and 7 more locations

Outcomes

Primary Outcomes

Remission According to DAS28-CRP at Week 16

Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16. DAS28-CRP is calculated with the following formula : 0.56\*SQRT TJC28+0.28\*SQRT SJC28+0.36\*ln (CRP+1)+0.014\*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.

Time frame: week 16

Remission According to DAS28-CRP at Week 52

Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 52. (co-primary end point) DAS28-CRP is calculated with the following formula : 0.56\*SQRT TJC28+0.28\*SQRT SJC28+0.36\*ln (CRP+1)+0.014\*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.

Time frame: week 52

Remission According to DAS28-CRP at Week 104

Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 104. (co-primary endpoints) DAS28-CRP is calculated with the following formula : 0.56\*SQRT TJC28+0.28\*SQRT SJC28+0.36\*ln (CRP+1)+0.014\*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.

Time frame: week 104

Secondary Outcomes

Remission According to SDAI (Simple Disease Activity Index) at Week 16

Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 16. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.

Time frame: week 16

Remission According to SDAI at Week 52

Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 52. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.

Time frame: week 52

Remission According to SDAI at Week 104

Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 104. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.

Time frame: week 104

Clinically Significant Change in HAQ Score

Number of patients with a change of \> 0.22 in the Health Assessment Questionnaire (HAQ) score over the period between baseline and week 104. A change of \> 0.22 in this score is considered as clinical relevant for rheumatoid arthritis patients.

Time frame: Baseline-week104