NCT00525213

Brief Summary

The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Oct 2007

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
9 countries

32 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

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

Enrollment Period

1.8 years

First QC Date

September 4, 2007

Last Update Submit

August 20, 2009

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.

    12 weeks

Secondary Outcomes (1)

  • Evaluate the safety of Rob 803 administered orally once daily in combination with a stable dose of methotrexate in subjects with moderate or severe active RA

    12 weeks

Study Arms (4)

A

ACTIVE COMPARATOR
Drug: Rob 803

B

ACTIVE COMPARATOR
Drug: Rob 803

C

ACTIVE COMPARATOR
Drug: Rob 803

D

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Rob 803DRUG

two capsules per day during 12 weeks

ABC
PlaceboDRUG

two capsules per day during 12 weeks

D

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with RA based on the ARA 1987 revised criteria at least 16 weeks prior to study enrolment, Day 0
  • Have an ACR global functional status class of 1 to 3
  • Have active disease, defined as the presence of 6 swollen joints and 6 tender joints in a 44 joint examination
  • Have a CRP level at screening of ≥ 1.5 mg/dL
  • Have been taking oral or parenteral methotrexate (15 mg weekly or above), have been using methotrexate for at least 16 weeks (up to Day 0 of study), and have been on a stable dose for at least 8 weeks, up to Day 0.

You may not qualify if:

  • Arthritis onset prior to 16 years old
  • Any of the following infections:
  • Known or acute infection that may affect CRP levels
  • Active tuberculosis
  • Known chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) including positive serology
  • Ongoing systemic inflammatory condition which may interfere with the results of clinical or laboratory tests planned in the study (eg, systemic lupus erythematosus or any other systemic rheumatic disease other than RA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

CUB Hôpital Erasme Université Libre de Bruxelles Service de Rhumatologie

Brussels, Belgium

Location

AZ Sint-Lucas Gent Reumatologie

Ghent, Belgium

Location

Reumainstituut Anne Frankplein 17

Hasselt, Belgium

Location

Clinic of Cardiology and Rheumatology UMHAT "Dr. Georgi Stranski"

Pleven, 5800, Bulgaria

Location

UMHAT sveti georgi

Ploviv, Bulgaria

Location

Clinic of Rheumatology MHAT "Sveti Ivan Rilski"

Sofia, 1431, Bulgaria

Location

Department of Rheumocardiology, Pulmonology and General Therapy

Sofia, 1874, Bulgaria

Location

Clinic of Rheumatology, UMHAT "Sveta Marina",

Varna, 9010, Bulgaria

Location

Academician V Tsitlanadze Scientific-Practical Centre of Rheumatolgoy

Tbilisi, Georgia

Location

Rheumatology Department Cemotherapy and Immunotherapy Clinical

Tbilisi, Georgia

Location

D Saulites-Kandevicas gimenes arsta prakse

Liepāja, Aldaru Iela 8,, LV 3401, Latvia

Location

Salenieces arsta reimatologa prakse

Valmiera, LV4201, Latvia

Location

Rheumatology Clinic Hospital of Kaunas University of Medicine

Kaunas, Lithuania

Location

Department of Therapy and diagnostics Siauliai district hospital

Šiauliai, Lithuania

Location

Center of Reumathology Vilnius University hospital Santariskiu Clinics

Vilnius, Lithuania

Location

Centrum Miriada Prywatny Gabinet

Bialystok, Zelazna 9, lok.13U, Poland

Location

Szpital Specjalistyczny Nr 1 Oddzial Reumatologii i Rehabilitacji

Bytom, 41-902, Poland

Location

Poznanski Osrodek Medyczny Nova Med

Poznan, Poland

Location

Indywidualna Specjalistyczna Praktyka

Szczecin, Poland

Location

Centrum Medyczne Osteomed

Warsaw, 02-256, Poland

Location

Prywatny Gabinet Lekarski

Wroclaw, Poland

Location

"Sf. Maria" Clinical Hospital

Bucharest, 011172, Romania

Location

"Dr. I. Cantacuzino" Clinical Hospital

Bucharest, 020475, Romania

Location

Emergency Clinical County Hospital

Cluj-Napoca, 400006, Romania

Location

"Dr. Constantin Papilian"

Cluj-Napoca, Romania

Location

Rehabilitation Clinical Hospital

Lasi, 700662, Romania

Location

Emergency County Hospital

Sibiu, Romania

Location

Institute of Rheumatology Belgrade

Belgrade, Serbia

Location

Institute for Prevention, Treatment and Rehabilitation of Rheumatic and Cardiovascular Diseases

Niška Banja, Serbia

Location

Reumatologiska kliniken Karolinska Sjukhuset

Stockholm, Sweden

Location

Musculo Skeletal dept Chapel Allerton Hospital

Leeds, United Kingdom

Location

Vectasearch Clinic Ltd St Mary's Hospital

Newport, United Kingdom

Location

Rheumatology Unit North Tyneside District General Hospital

North Shields, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

9-chloro-2,3-dimethyl-6-(N,N-dimetylamino-2-oxoethyl)-6H-indolo(2,3-b)quinoxaline

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lars Klareskog, Professor

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

October 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

GB(4)LI(3)PL(6)BU(5)GE(2)LA(2)BE(3)SE(1)RO(6)