Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT00583557
Eligibility Criteria:
Primary Inclusion Criteria:
1. Have completed the LBRA01 trial.
2. Have achieved at least an ACR20 response at the end of LBRA01.
Primary Exclusion Criteria:
1. Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01.
2. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01.
3. Used prohibited medications during their participation in LBRA01. These medications include the following:
* Other investigational agents.
* Biologic response modifiers
* Cyclophosphamide.
* Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months).
* 2 new DMARDs.
* 1 new DMARD plus high dose prednisone \>10 mg/day.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00583557
Study Brief:
Protocol Section:
NCT00583557