Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

March 28, 2001

Primary Completion Date

May 31, 2006

Study Completion Date

May 31, 2006

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Combination of Minocycline and MTX or MTX alone

"Methotrexate Dosing:~1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week.~3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week.~4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg"

DRUG

methotrexate

"Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week.~2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week.~4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week.~6, 8 and 10 month evaluations:~If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week.~If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 12 month evaluation: End of the blinded portion of the study."

Trial Locations (1)

68198

Unversity of Nebraska Medical Center, Omaha

All Listed Sponsors
lead

University of Nebraska

OTHER

NCT00579644 - Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone | Biotech Hunter | Biotech Hunter