Skip to content

A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516723-14-00
Acronym
NORD-STAR
Enrollment
705
Registered
2024-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

Treatment Part 1: The primary efficacy outcome is the proportion of patients in remission at week 24 from baseline according to CDAI. Treatment Part 1: The primary radiographic outcome is the progression of total Sharp van der Heijde score after 48 weeks from baseline. Treatment Part 2: The primary efficacy outcome is the proportion of patients in remission according to CDAI, at the time point 24 weeks after the dose was first reduced.

Interventions

DRUGHYDROXYCHLOROQUINE
DRUGABATACEPT
DRUGAZATHIOPRINE
DRUGSULFASALAZINE
DRUGMETHOTREXATE
DRUGLEFLUNOMIDE
DRUGRoActemra 20 mg/mL concentrate for solution for infusion
DRUGPREDNISOLONE
DRUGTriamcinolone Hexacetonide 20 mg/ml suspension for injection

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Treatment Part 1: The primary efficacy outcome is the proportion of patients in remission at week 24 from baseline according to CDAI. Treatment Part 1: The primary radiographic outcome is the progression of total Sharp van der Heijde score after 48 weeks from baseline. Treatment Part 2: The primary efficacy outcome is the proportion of patients in remission according to CDAI, at the time point 24 weeks after the dose was first reduced.

Countries

Denmark, Iceland, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026