Initial Treatment With Golimumab in Early PsA
The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate alone is started. Golimumab will be discontinued.
First, the investigators hypothesize that initiation of a combination therapy with golimumab + MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the percentage of patients achieving Disease Activity Score (the investigators hypothesize that more patients with the early combination treatment will respond (according to Disease Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis Response Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or Minimal Disease Activity (MDA) than patients on MTX alone.
Third, the investigators hypothesize that a significant proportion of the patients will continue to benefit from this early aggressive treatment initiation even after stopping golimumab treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled Trial of Golimumab+Methotrexate Versus Methotrexate Alone in Methotrexate-naïve Patients With Psoriatic Arthritis|
- Percentage of patients achieving DAS remission response criteria [ Time Frame: week 22 ] [ Designated as safety issue: No ]
1. To demonstrate that golimumab + MTX is superior to MTX alone in achieving DAS remission in MTX naïve PsA patients at week 22
DAS = Disease activity score, remission is defined as a DAS < 1.6
- Number of Participants with Adverse Events [ Time Frame: week 22 ] [ Designated as safety issue: Yes ]
Number of patients with(severe) adverse events (and type) during the study period.
Safety will be monitored during the study period by laboratory tests and physical examination.
- Number of patients fulfilling Minimal Disease activity criteria and other outcome measurements [ Time Frame: week 22 ] [ Designated as safety issue: No ]To demonstrate that golimumab + MTX is superior to MTX alone as assessed by DAS, ACR and PsARC responses, as well as by achievement of low disease activity (LDA, as defined by DAS<2.4) and minimal disease activity (MDA, as defined by Coates et al, Ann Rheum Dis 2010). Also the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score and Psoriasis Area Severity Index (PASI) score will be determined in MTX naïve PsA patients at week 22.
- Efficacy after withdrawing anti-TNF [ Time Frame: week 50 ] [ Designated as safety issue: No ]To demonstrate that initial treatment of MTX naïve patients with golimumab + MTX is superior to MTX alone to maintain DAS (disease activity score) remission, LDA (Low Disease Activity) and MDA over time (up to week 50) after withdrawing golimumab.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: methotrexate
methotrexate is the active comparator, it will be compared to golimumab + methotrexate
Methotrexate will be started at a dosage of 15 mg/week orally and, if well tolerated, increased to 20mg/week at week 4 and 25mg/week at week 8 of the trial. If well tolerated, the maximum dose of 25 mg/week will be sustained until end of study (week 50). Folic acid 5 mg/week will be administered orally one day after the MTX intake.
Other Name: N.A.
Experimental: golimumab and methotrexate
The combination of golimumab en methotrexate will be compared to methotrexate alone.
golimumab 50mg subcutaneous injections (in combination with methotrexate), once a month, for a period of 22 weeks
Other Name: simponi
Please refer to this study by its ClinicalTrials.gov identifier: NCT01871649
|Contact: Dominique LP Baeten, Prof. dr. MD||+31 20 email@example.com|
|Contact: Leonieke JJ Van Mens, MD||+31 20 firstname.lastname@example.org|
|Academic Medical Center/University of Amsterdam||Recruiting|
|Amsterdam, Noord Holland, Netherlands, 1105 AZ|
|Contact: Dominique LP Baeten, Prof. dr. MD +31 20 5667765 email@example.com|
|Contact: Leonieke JJ Van Mens, MD +31 20 5667765 firstname.lastname@example.org|
|Principal Investigator: Dominique LP Baeten, Prof dr MD|
|Amsterdam, Noord Holland, Netherlands, 1056 AB|
|Contact: Arno WR Van Kuijk, MD, PhD +31 20 5896589 email@example.com|
|Contact: Leonieke Van Mens, MD +31 205896222 firstname.lastname@example.org|
|Principal Investigator: Arno WR Van Kuijk, MD PhD|
|Principal Investigator:||Dominique LP Baeten, Prof. dr. MD||Academic Medical Center, University of Amsterdam|