Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
CSL Behring
Study ID
NCT02015520
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary purpose of this study is to identify an appropriate dose of study medication.

Key Dates

First listed
Dec 19, 2013
Start date
Jun 30, 2012
Status verified
Apr 2021
Primary completion
Jun 30, 2013
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: Arm 1: Clazakizumab (Dose # A) (Double-Blind)
    Clazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate
  • Experimental: Arm 2: Clazakizumab (Dose # B) (Double-Blind)
    Clazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate
  • Experimental: Arm 3: Clazakizumab (Dose # C) (Double-Blind)
    Clazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate
  • Experimental: Arm 4: Placebo matching with Clazakizumab (Double-Blind)
    Clazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate

Primary Outcome Measure

Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (21)

FacilityCityStateZIPSite coordinators
Rheumatology Associates Of North Alabama, P.C.HuntsvilleAlabama35801-
Mercy Clinic Hot Springs CommunitiesHot SpringsArkansas71913-
Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.Long BeachCalifornia90806-
Desert Medical AdvancesPalm DesertCalifornia92260-
Sarasota Arthritis Research CenterSarasotaFlorida34239-
Clinical Pharmacology Study GroupWorcesterMassachusetts01605-
St. Paul Rheumatology, P.A.EaganMinnesota55121-
Physician Research Collaboration, LlcLincolnNebraska68516-
Albuquerque Center For RheumatologyAlbuquerqueNew Mexico87102-
Albuquerque Clinical TrialsAlbuquerqueNew Mexico87102-
Joint And Muscle Medical Care And Research Institute (Jmmcri)CharlotteNorth Carolina28204-
Physicians East, PaGreenvilleNorth Carolina27834-
Cincinnati Rheumatic Disease Study GroupCincinnatiOhio45219-
Paramount Medical Research & Consulting, LlcMiddleburg HeightsOhio44130-
Arthritis & Rheumatology Center Of Oklahoma PllcOklahoma CityOklahoma73103-
Health Research Of OklahomaOklahoma CityOklahoma73103-
Healthcare Research ConsultantsTulsaOklahoma74135-
Low Country RheumatologyCharlestonSouth Carolina29406-
Rheumatology Consultants PllcKnoxvilleTennessee37909-
Center For Inflammatory DiseaseNashvilleTennessee37203-
Seattle Rheumatology AssociatesSeattleWashington98122-

Find similar trials in Huntsville, AL

Nationwide
Rheumatoid arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials
By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Rheumatology Associates Of North Alabama, P.C.· Huntsville, ALMercy Clinic Hot Springs Communities· Hot Springs, ARValerius Med Group & Res Ctr Of Greater Long Beach, Inc.· Long Beach, CADesert Medical Advances· Palm Desert, CASarasota Arthritis Research Center· Sarasota, FLClinical Pharmacology Study Group· Worcester, MA

Related Studies