Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

Sponsor
UCB Celltech
Study ID
NCT02430909
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bimekizumab — BIOLOGICAL
    * Pharmaceutical form: Solution for infusion * Concentration: Vials at 80 mg/ml will be diluted with 0.9% sodium chloride to a final concentration to achieve the correct dose * Route of administration: iv infustion
  • Certolizumab Pegol — BIOLOGICAL
    * Pharmaceutical form: Prefilled syringes * Concentration: 200 mg/ml * Route of administration: Subcutaneous injection
  • Placebo — OTHER
    * Pharmaceutical form: Solution for infusion * Concentration: 0.9% saline * Route of administration: Intravenous infusion

Study Details

The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.

Key Dates

Start date
Apr 30, 2015
Status verified
May 2017
Primary completion
Apr 30, 2017
Completion
Apr 30, 2017

Study Design

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

Arms

  • Placebo Comparator: CZP / CZP + PBO / CZP
    Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30 +Placebo from Week 8 to Week 18
  • Experimental: CZP / CZP + UCB4940 / CZP
    Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30 \+ UCB4940 from Week 8 until Week 18
  • Other: CZP / CZP/ CZP
    Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Screening (D-28) until final study visit (Week 44) ]

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