A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
- Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
- Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
- Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
- Others as defined in the protocol
Exclusion Criteria:
- Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
- Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening.
- Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA.
- Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
- Others as defined in the protocol.
Sites / Locations
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator site
- Investigator Site
- Investigator site
- Investigator site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site 1
- Investigator Site 2
- Investigator Site 1
- Investigator Site 2
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site 1
- Investigator Site 2
- Investigator Site
- Investigator Site
- Investigator Site 1
- Investigator Site 2
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site 1
- Investigator Site 2
- Investigator Site 1
- Investigator Site 2
- Investigator Site
- Investigator Site
- Investigator Site 1
- Investigator Site 2
- Investigator Site
- Investigator Site 2
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator SIte
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site 1
- Investigator Site 2
- Investigator Site 3
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site
- Investigator Site 2
- Investigator Site 1
- Investigator Site 2
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
ALX-0061 150 mg q4w
ALX-0061 150 mg q2w
ALX-0061 225 mg q2w
TCZ 162 mg q1w or q2w
ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).