NCT00867516

Brief Summary

The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

Geographic Reach
6 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 9, 2020

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

March 20, 2009

Last Update Submit

July 7, 2020

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of AEs and SAEs during the study

    During entire length of study

Secondary Outcomes (1)

  • To evaluate the difference in treatment with ALD518 relative to treatment with placebo in the proportion of patients achieving a 20% improvement in ACR response (ACR20) at Week 12

    12 weeks after Dose 1

Study Arms (4)

1

EXPERIMENTAL

ALD518 80 mg

Biological: ALD518

2

EXPERIMENTAL

ALD518 160 mg

Biological: ALD518

3

EXPERIMENTAL

ALD518 320 mg

Biological: ALD518

4

PLACEBO COMPARATOR

No ALD518

Biological: Infusion without ALD518'

Interventions

ALD518BIOLOGICAL

Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8

123
Infusion without ALD518'BIOLOGICAL

250 cc Normal saline IV over one hour Weeks 1 and 8.

4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active Rheumatoid Arthritis for at least 16 weeks duration
  • Have a C-reactive protein (CRP) of ≥ 10mg/L
  • Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months

You may not qualify if:

  • Arthritis onset prior to 16 years old
  • Received any biologic therapy in the previous 12 months
  • A history of or currently have active tuberculosis
  • Any clinically significant concurrent medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

K-W Musculoskeletal Research, Inc.

Kitchener, Ontario, N2M 5N6, Canada

Location

Rheumatology Research Associates

Ottawa, Ontario, KIH IA2, Canada

Location

V. Tsitlanadze Scientific Practical Centre of Rheumatology

Tbilisi, 0102, Georgia

Location

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi, 0186, Georgia

Location

Chanre Rheumatology and Immunology Center and Research

Malleshwaram, Bangalore, 560 003, India

Location

KLE Society Hospital and Medical Research Centre

Nehru Nagar, Belgaum, 590 010, India

Location

Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics

Ramadaspeth, Nagpur, 440 010, India

Location

St. John's Medical College Hospital

Bangalore, 560 034, India

Location

Krishna Institute of Medical Sciences Ltd.

Secunderabad, 500 003, India

Location

Miriada Center Private Clinic of Professor Sierakowski

Bialystok, 15-297, Poland

Location

Nonpublic Centre of Medical Care Reumed

Lublin, 26-607, Poland

Location

NOVAMED - Medical Center of Poznan

Poznan, 60-773, Poland

Location

Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko

Sopot, 81-759, Poland

Location

Szezecin Clinic of Rheumatology and Internal Diseases

Szczecin, 71-252, Poland

Location

Regional Clinical Hospital of War Veterans

Kemerovo, 650099, Russia

Location

Institute of Clinical and Experimental Lymphology

Novosibirsk, 630117, Russia

Location

Ryazan Regional Clinical Cardiologic Dispensary

Ryazan, 390026, Russia

Location

Saint Petersburg Medical Academy of Postgraduate Study

Saint Petersburg, 191015, Russia

Location

Saint-Petersburg State Medical Academy named after I. I. Mechnikov

Saint Petersburg, 195067, Russia

Location

City Hospital #26

Saint Petersburg, 196247, Russia

Location

Regional War Veterans' Hospital

Saratov, 410002, Russia

Location

Tomsk Regional Clinical Hospital

Tomsk, 634063, Russia

Location

Tula Regional Clinical Hospital

Tula, 300053, Russia

Location

Clinical Hospital of Emergency Care named after N.V. Solovyev

Yaroslavl, 150003, Russia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Institute for Rehabilitation and Treatment Niska Banja

Niška Banja, 18205, Serbia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

clazakizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jeffrey Smith, MD, FRCP

    Alder BioPharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2009

First Posted

March 23, 2009

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

July 9, 2020

Record last verified: 2017-09

Locations

IN(5)PL(5)SE(2)GE(2)CA(2)RU(10)