A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ablynx, a Sanofi company
Study ID
NCT02287922
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • ALX-0061 — BIOLOGICAL
  • Placebo — BIOLOGICAL
  • Tocilizumab — BIOLOGICAL

Study Details

The primary objective of this study is: \- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). The secondary objectives of this study are: * To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development. * To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.

Key Dates

Start date
Mar 31, 2015
Status verified
Aug 2019
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
251 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALX-0061 150 mg q4w
    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.
  • Experimental: ALX-0061 150 mg q2w
    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.
  • Experimental: ALX-0061 225 mg q2w
    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.
  • Active Comparator: TCZ 162 mg q1w or q2w
    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).

Primary Outcome Measure

Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12 [ Time Frame: Week 12 ]

Locations (17)

FacilityCityStateZIPSite coordinators
Investigator SiteBirminghamAlabama35216-
Investigator SiteHemetCalifornia92543-
Investigator SiteLa PalmaCalifornia90712-
Investigator siteLos AngelesCalifornia90017-
Investigator SiteLos AngelesCalifornia90036-
Investigator siteVenturaCalifornia93003-
Investigator siteHialeahFlorida33016-
Investigator SiteHomesteadFlorida33030-
Investigator SiteOrlandoFlorida32804-
Investigator SiteStockbridgeGeorgia30281-
Investigator siteOverland ParkKansas66209-
Investigator SiteWorcesterMassachusetts01605-
Investigator SiteAlbuquerqueNew Mexico87102-
Investigator SiteNew YorkNew York10018-
Investigator SiteCharlestonSouth Carolina29406-
Investigator SiteMemphisTennessee38119-
Investigator SiteMesquiteTexas75150-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Investigator Site· Birmingham, ALInvestigator Site· Hemet, CAInvestigator Site· La Palma, CAInvestigator site· Los Angeles, CAInvestigator Site· Los Angeles, CAInvestigator site· Ventura, CA

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