E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
active psoriatic arthritis |
actieve artritis psoriatica |
|
E.1.1.1 | Medical condition in easily understood language |
psoriatic arthritis |
artritis psoriatica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in methotrexaat naïve PsA patients
|
aantonen dat golimumab+MTX combinatie effectief en veilig is t.o.v. MTX alleen in methotrexaat naieve PsA patienten |
|
E.2.2 | Secondary objectives of the trial |
- to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in MTX naïve PsA patients
- to demonstrate that initial treatment of MTX naïve patients with golimumab + MTX is superior to MTX alone to maintain low to very low disease activity over time after withdrawing golimumab treatment |
- aantonen dat golimumab+MTX combinatie therapie beter is dan alleen MTX om een lage tot zeer lage ziekte activiteit te krijgen in MTX-naieve PsA patienten
- aantonen dat in MTX naieve PsA patienten die in de beginfase behandeld worden met combinatietherapie Golimumab+MTX beter is dan alleen MTX voor het behouden van lage tot zeer lage ziekteactiviteit, ook na het staken van golimumab behandeling |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Psoriatic arthritis according to the CASPAR classification
- Active disease, minimally 3 swollen and tender joints
- 18-70 years
- a stable dose of concomitant NSAIDs and/or corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent ≤ 10 mg/day and must be stable for at least 4 weeks prior to baseline.
- Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest X-ray and electrocardiography (ECG). |
Artritis psoriatica volgens CASPAR criteria
Actieve ziekte minimaal 3 gezwollen en pijnlijke gewrichten
18-70 jaar
stabiele dosis NSAID en/corticosteroiden zijn toegestaan. De corticosteroiden dosering mag niet een prednison equivalent ≤ 10 mg/dag overschrijden en de dosering moet stabiel zijn voor tenminste 4 wkn vooraf aan baseline
Patienten worden beschouwd als in goede algemene gezondheid gebaseerd op medische voorgeschiedenis, lichamelijk onderzoek, laboratoriumuitslagen, rontgenfoto van de longen en een ECG |
|
E.4 | Principal exclusion criteria |
Methotrexate naive
TNF blocker naive
Concurrent DMARD use
Malignancy <5 years ago
no active children wish, pregnancy or breast feeding |
Methotrexaat naief
anti-TNF naief
gezamelijk DMARD gebruik
Maligniteit <5jaar geleden
Geen active kinderwens, zwangerschap of borstvoeding gevend |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Safety
- DAS remission |
- Veiligheid
- DAS remissie |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- EULAR DAS response
- ACR20, ACR50 and ACR70
- PsARC
- PASI75
- Leeds Enthesitis Index (LEI)
- Dactylitis
- Changes in HAQ
- % of patients achieving low disease activity (defined as DAS <2.4)
- % of patients achieving minimal disease activity (as defined by Coates et al, Ann Rheum Dis 2010)
Exploratory:
- Safety
- EULAR response, ACR20/50/70 and PsARC
- Survival analysis of patients remaining in DAS remission
- Survival analysis of patients retaining low disease activity (defined as DAS <2.4)
- Survival analysis of patients retaining minimal disease activity (as defined by Coates et al, Ann Rheum Dis 2010) |
- EULAR DAS respons
- ACR20, ACR50 & ACR70
- PsARC
- PASI75
- Leeds Enthesitis Index (LEI)
- Dactylitis
- Veranderingen in HAQ
- % van patienten die de low disease activity (gedefinieerd als DAS <2.4)
- % van patienten die minimale ziekte activiteit bereiken (gedefinieerd door Coates et al, Ann Rheum Dis 2010)
Exploratory:
- Veiligheid
- EULAR respons, ACR20/50/70 & PsARC
- Survival analyse van patienten blijvend in DAS remission
- Survival analyse van patienten blijvend in lage ziekteactiviteit (gedefinieerd als DAS <2.4)
- Survival analyse van patienten blijvend in minimale ziekte activiteit (gedefinieerd door Coates et al, Ann Rheum Dis 2010) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
first 22 weeks randomized, double-blind, placebo-controlled phase; last 28 weeks open label extensi |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
see protocol |
zie protocol |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |