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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00361335




Registration number
NCT00361335
Ethics application status
Date submitted
4/08/2006
Date registered
8/08/2006
Date last updated
29/07/2014

Titles & IDs
Public title
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Secondary ID [1] 0 0
C0524T12
Secondary ID [2] 0 0
CR012781
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Golimumab
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo

Experimental: Group I: 2mg/kg Golimumab + MTX - Intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (an additional 2mg/kg IV infusion of golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive methotrexate (MTX) at the same dose as that before study entry

Experimental: Group II: 2mg/kg Golimumab only - IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX or switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive placebo (sham MTX) capsules

Experimental: Group III: 4mg/kg Golimumab + MTX - IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive MTX at the same dose as that before study entry.

Experimental: Group IV: 4mg/kg Golimumab only - IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive placebo (sham MTX) capsules.

Placebo Comparator: Group V: IV Placebo + MTX - IV infusions of placebo at Week 0 and Week 12 with early escape (switch to 4mg/kg IV golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (placebo plus golimumab) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition patients will receive MTX at the same dose as that before study entry. Participants still receiving placebo injections at Week 48 are not eligible to enter the Extension Study.


Treatment: Drugs: Golimumab
2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes

Treatment: Drugs: Methotrexate
Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.

Treatment: Drugs: Placebo
Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 - An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
Timepoint [1] 0 0
Week 0 to Week 14
Secondary outcome [1] 0 0
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24 - ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).
Timepoint [1] 0 0
Week 0 to Week 24
Secondary outcome [2] 0 0
Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 - ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).
Timepoint [2] 0 0
Week 0 to Week 14
Secondary outcome [3] 0 0
Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14 - DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A "Moderate" response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2
Timepoint [3] 0 0
Week 0 to Week 14
Secondary outcome [4] 0 0
Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14 - The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.
Timepoint [4] 0 0
Weeks 0 to Week 14

Eligibility
Key inclusion criteria
- Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987
criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender
joints for at least 3 months prior to screening - Have been treated with and tolerated
methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to
screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and
less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non
steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must
be on a stable dose for at least 2 weeks prior to the first administration of study agent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants having known hypersensitivity (severe allergy) to human immunoglobulin
proteins or other components of golimumab - Having known clinically serious adverse
reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous
infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to
screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Fitzroy
Recruitment hospital [2] 0 0
- Heidelberg
Recruitment hospital [3] 0 0
- Maroochydore
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Perth
Recruitment hospital [6] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Fitzroy
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
Rosario
Country [15] 0 0
Argentina
State/province [15] 0 0
San Juan
Country [16] 0 0
Argentina
State/province [16] 0 0
San Miguel De Tucuman
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Colombia
State/province [18] 0 0
Barranquilla
Country [19] 0 0
Colombia
State/province [19] 0 0
Bogota
Country [20] 0 0
Colombia
State/province [20] 0 0
Bucaramanga
Country [21] 0 0
Colombia
State/province [21] 0 0
Floridablanca
Country [22] 0 0
Germany
State/province [22] 0 0
Erlangen
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Magdeburg
Country [25] 0 0
Germany
State/province [25] 0 0
München
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Szolnok
Country [28] 0 0
Latvia
State/province [28] 0 0
Daugavpils
Country [29] 0 0
Latvia
State/province [29] 0 0
Riga
Country [30] 0 0
Lithuania
State/province [30] 0 0
Kaunas
Country [31] 0 0
Lithuania
State/province [31] 0 0
Klaipeda
Country [32] 0 0
Lithuania
State/province [32] 0 0
Siauliai
Country [33] 0 0
Lithuania
State/province [33] 0 0
Vilnius
Country [34] 0 0
Malaysia
State/province [34] 0 0
Ipoh
Country [35] 0 0
Malaysia
State/province [35] 0 0
Kuching
Country [36] 0 0
Malaysia
State/province [36] 0 0
Precinct 7
Country [37] 0 0
Malaysia
State/province [37] 0 0
Selangor Darul Ehasan
Country [38] 0 0
Malta
State/province [38] 0 0
Msd06 Gwardiamangia
Country [39] 0 0
Mexico
State/province [39] 0 0
Col. Del Valle
Country [40] 0 0
Mexico
State/province [40] 0 0
Guadalajara Jalisco
Country [41] 0 0
Mexico
State/province [41] 0 0
Guadalajara N/A
Country [42] 0 0
Mexico
State/province [42] 0 0
Monterrey
Country [43] 0 0
New Zealand
State/province [43] 0 0
Christchurch
Country [44] 0 0
New Zealand
State/province [44] 0 0
Dunedin
Country [45] 0 0
New Zealand
State/province [45] 0 0
Rotorua
Country [46] 0 0
New Zealand
State/province [46] 0 0
Takapuna Auckland
Country [47] 0 0
New Zealand
State/province [47] 0 0
Timaru
Country [48] 0 0
Peru
State/province [48] 0 0
Lima
Country [49] 0 0
Poland
State/province [49] 0 0
Bialystok
Country [50] 0 0
Poland
State/province [50] 0 0
Elblag
Country [51] 0 0
Poland
State/province [51] 0 0
Krakow
Country [52] 0 0
Poland
State/province [52] 0 0
Warszawa
Country [53] 0 0
Poland
State/province [53] 0 0
Wloszczowa
Country [54] 0 0
Ukraine
State/province [54] 0 0
Kiev
Country [55] 0 0
Ukraine
State/province [55] 0 0
Kyiv
Country [56] 0 0
Ukraine
State/province [56] 0 0
Symferpol
Country [57] 0 0
Ukraine
State/province [57] 0 0
Zhaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Centocor, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Schering-Plough
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the clinical effectiveness and safety of golimumab
intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with
MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX
treatment. In addition, the safety of subcutaneous (SC) golimumab injections following
transition from IV golimumab infusions will also be evaluated.
Trial website
https://clinicaltrials.gov/show/NCT00361335
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Centocor, Inc. Clinical Trial
Address 0 0
Centocor, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications