Features and properties of the multicentre, active-comparator VOLTAIRE randomised controlled trials
| RCT details | VOLTAIRE-RA6
(NCT02137226) | VOLTAIRE-CD7
(NCT02871635) | VOLTAIRE-PsO8
(NCT02850965) |
| Participants | Moderate-to-severe RA | Active CD (CDAI 220–450) | Moderate-to-severe PsO |
| Primary outcome | ACR20 at weeks 12 and 24 | CDAI decrease ≥70 points at week 4 | PASI 75 at week 16 |
| Background therapy | Methotrexate (15–25 mg/week; 10–14 mg/week permitted if intolerant) | Stable doses of DMARDs allowed | No |
| Study duration | 58 weeks | 56 weeks | 34 weeks |
| Intervention (n) | Adalimumab-adbm (n=324) Adalimumab RP (n=321) | Adalimumab-adbm (n=72) Adalimumab RP (n=75)* | Adalimumab-adbm (n=159) Adalimumab RP (n=158) |
| Dosage regimen | 40 mg every 2 weeks | Loading doses of 160 mg on day 1 and 80 mg on day 15 then 40 mg every 2 weeks maintenance | Loading doses of 80 mg on day 1 and 40 mg day 8 then 40 mg every 2 weeks every two maintenance |
| Previous biologics | Allowed | Allowed | Allowed |
| Key time points† | Week 24: Rerandomisation adalimumab RP group (either continued adalimumab RP or switched to adalimumab-adbm) and dummy rerandomisation adalimumab-adbm group (continued medication)‡ | Week 4: CDAI response evaluated§; responders continued in trial to week 24: patients unmasked; adalimumab RP group switched to adalimumab-adbm, adalimumab-adbm group continued medication | Week 16 PASI 50 response evaluated¶; responders continued to week 24 |
| Immunogenicity time points | Baseline, post dose: weeks 1, 2, 4, 12, 24, 40 and 48 | Baseline, post dose: weeks 4, 24 and 48 | Baseline, post dose: weeks 16 and 24 |
*Randomisation stratified by previous exposure to infliximab (yes vs no) and simple endoscopic score for CD at screening (<16 vs ≥16).
†Each trial included 10-week safety follow-up.
‡Qualifying patients could enter open-label extension (VOLTAIRE-RAext; NCT02640612).
§≥70-point decrease from baseline.
¶≥50% reduction from baseline.
ACR20, American College of Rheumatology 20% response criteria; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; DMARD, disease-modifying antirheumatic drug; PASI, Psoriasis Area and Severity Index; PASI 50/PASI 75, 50% or 75% reduction in PASI, respectively; PsO, chronic plaque psoriasis; RA, rheumatoid arthritis; RP, reference product.