Trials / Completed
CompletedNCT00367237
Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)
A Randomized, Multicenter, International, Open-label Study of Infliximab Plus Methotrexate Versus Methotrexate (MTX) Alone for the Treatment of MTX naïve Subjects With Active Psoriatic Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Infliximab + methotrexate (IFX + MTX) | Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6. |
| DRUG | Methotrexate (MTX) | Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6. |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2006-08-22
- Last updated
- 2017-04-11
- Results posted
- 2009-07-07
Source: ClinicalTrials.gov record NCT00367237. Inclusion in this directory is not an endorsement.