1) to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in DMARD naïve PsA patients2) to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in DMARD naïve PsA patients3) to…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Safety up till week 22
- DAS remission up till week 22
Secondary outcome
- EULAR DAS response at week 22
- ACR20, ACR50 and ACR70 at week 22
- PsARC at week 22
- PASI75 at week 22
- Leeds Enthesitis Index (LEI) at week 22
- Dactylitis at week 22
- Changes in HAQ between baseline and week 22
- % of patients achieving low disease activity (defined as DAS <2.4) at week 22
- % of patients achieving minimal disease activity (as defined by Coates et al,
Ann Rheum Dis 2010) at week 22
Exploratory:
- Safety up to week 50
- EULAR response, ACR20/50/70 and PsARC at week 50
- Survival analysis of patients remaining in DAS remission up to week 50
- Survival analysis of patients retaining low disease activity (defined as DAS
<2.4) up to week 50
- Survival analysis of patients retaining minimal disease activity (as defined
by Coates et al, Ann Rheum Dis 2010) up to week 50
Background summary
PsA is a chronic, inflammatory disease, affecting approximately 30% of the
patients with psoriasis. The majority of these patients have physical
impairments, work-related impairments and decreased quality of life.
The disease burden is variable but can extent to permanent radiographic joint
damage, deformities and limitation in function. The responses to DMARD
treatment (Methotrexate, leflunomide) is suboptimal and evidence is limited for
these therapies in PsA.
Anti-TNF therapy (golimumab) has proven efficacy on joints and skin disease in
PsA. In most countries patients are first treated with a DMARD and only when
failing anti-TNF is considered.
First line use of anti-TNF treatment is not asessed previously. Therefore
assessing if the first line treatment with anti-TNF in combination with
methotrexate is more effective compared with methotrexate alone is assessed.
Study objective
1) to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone
in DMARD naïve PsA patients
2) to demonstrate that golimumab + MTX is superior to MTX alone to achieve low
to very low disease activity in DMARD naïve PsA patients
3) to demonstrate that initial treatment of DMARD naïve patients with golimumab
+ MTX is superior to MTX alone to maintain low to very low disease activity
over time after withdrawing golimumab treatment
Study design
A randomized clinical trial in psoriatic arthritis patients in which patients
either recieve golimumab together with methotrexate or receive methotrexate
alone in the double blind phase (1:1) during a period of 22 weeks. In the open
label everyone will receive methotrexate but no golimumab, up till week 50.
Study burden and risks
- methotrexate is given in this study, but is also first choice treatment
regimen in the outpatient clinics.
- golimumab is given second line, after limited/no response to methotrexate in
standard medical practice.
- This medicine has side effects (such as less resistance, skin reaction at
place of s.c. injection and tuberculosis reactivation in case of latent TB),
but these are not extensively
- patientswill have to visit the outpatient clinic 8 times, filling in
questionnaires (15min), asessing medical history and undergo medical
examination, venapuncture, Xray of hand and feet (only visit 0 and week 50), a
chest x-ray (one time), PPD skin test , and if relevant pregnancy tests.
X-ray radiation used in this study is low.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Psoriatic arthritis according to the CASPAR classification
Active disease, with a minimal of 3 swollen and tender joints
18-70 years
Exclusion criteria
Methotrexate naive
TNF blocker naive
Concurrent and previous DMARD use
Malignancy <5 years age
active children wish, pregnancy or breast feeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-005214-19-NL |
| CCMO | NL42670.018.12 |