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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00264550




Registration number
NCT00264550
Ethics application status
Date submitted
11/12/2005
Date registered
13/12/2005
Date last updated
29/04/2014

Titles & IDs
Public title
An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy
Secondary ID [1] 0 0
C0524T06
Secondary ID [2] 0 0
CR006343
Universal Trial Number (UTN)
Trial acronym
GO-FORWARD
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 100 mg
Treatment: Drugs - Golimumab 50 mg
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo injection
Treatment: Drugs - Placebo capsules

Placebo Comparator: Group 1: Placebo + Methotrexate - Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.

Experimental: Group 2: Golimumab 100 mg + Placebo - Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7-10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.

Experimental: Group 3: Golimumab 50 mg + Methotrexate - Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.

Experimental: Group 4: Golimumab 100 mg + Methotrexate - Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.


Treatment: Drugs: Golimumab 100 mg
Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.

Treatment: Drugs: Golimumab 50 mg
Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.

Treatment: Drugs: Methotrexate
Participants will receive methotrexate capsules weekly.

Treatment: Drugs: Placebo injection
Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.

Treatment: Drugs: Placebo capsules
Participants will receive placebo capsules weekly

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

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 - ACR 20 response is defined as a greater than or equal to 20 percent 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 of pain by the Visual Analogue Scale (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.
Timepoint [1] 0 0
Week 14
Primary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 - HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
Timepoint [2] 0 0
Baseline (Week 0) and Week 24
Secondary outcome [1] 0 0
Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14 - DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).
Timepoint [1] 0 0
Week 14
Secondary outcome [2] 0 0
Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24 - An ACR 20 response is defined as a greater than or equal to 20 percent 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 [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14 - The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
Timepoint [3] 0 0
Baseline (Week 0) and Week 14
Secondary outcome [4] 0 0
Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24 - The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.
Timepoint [4] 0 0
Baseline (Week 0) and Week 24

Eligibility
Key inclusion criteria
- Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria
of the ACR) for at least 3 months prior to screening

- Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15
mg/week for at least 3 months prior to screening, and have a MTX dose of >=15 mg/week
and <=25 mg/week and stable for at least 4 weeks prior to screening

- Have active RA as defined by persistent disease activity with at least 4 swollen and 4
tender joints, at the time of screening and baseline, and at least 2 of the following
4 criteria: a)C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte
sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at
screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline,
c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first
administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP)
antibody-positive or rheumatoid factor (RF) positive at screening

- If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of
prednisone/day for at least 2 weeks prior to first administration of study agent

- Are considered eligible according to specified tuberculosis (TB) screening criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have inflammatory diseases other than RA that might confound the evaluation of the
benefit of golimumab therapy

- Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic
immunosuppressives other than MTX, during the 4 weeks prior to the first
administration of study agent

- Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs
(infliximab, etanercept, adalimumab)

- Have had history of, or ongoing, chronic or recurrent infectious disease.

- Have serious infection within 2 months prior to first administration of study agent

- Have a history of latent or active granulomatous infection, including TB,
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
- Clayton
Recruitment hospital [2] 0 0
- Maroochydore
Recruitment hospital [3] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Maroochydore
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Cordoba
Country [11] 0 0
Argentina
State/province [11] 0 0
Rosario
Country [12] 0 0
Argentina
State/province [12] 0 0
S.M. De Tucuman
Country [13] 0 0
Argentina
State/province [13] 0 0
San Miguel De Tucuman
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Newfoundland and Labrador
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Canada
State/province [18] 0 0
Hamilton Ontario
Country [19] 0 0
Chile
State/province [19] 0 0
Rancagua
Country [20] 0 0
Chile
State/province [20] 0 0
Santiago De Chile
Country [21] 0 0
Chile
State/province [21] 0 0
Santiago
Country [22] 0 0
Chile
State/province [22] 0 0
Temuco Ix
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hannover
Country [26] 0 0
Germany
State/province [26] 0 0
Köln
Country [27] 0 0
Germany
State/province [27] 0 0
Leipzig
Country [28] 0 0
Germany
State/province [28] 0 0
Rostock
Country [29] 0 0
Hungary
State/province [29] 0 0
Budepest
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Anyang
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Daegu
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Pusan
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Mexico
State/province [34] 0 0
Monterrey
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
New Zealand
State/province [36] 0 0
Rotorua
Country [37] 0 0
New Zealand
State/province [37] 0 0
Timaru
Country [38] 0 0
Poland
State/province [38] 0 0
Elblag
Country [39] 0 0
Poland
State/province [39] 0 0
Kalisz
Country [40] 0 0
Poland
State/province [40] 0 0
Szczecin
Country [41] 0 0
Poland
State/province [41] 0 0
Warsaw
Country [42] 0 0
Poland
State/province [42] 0 0
Warszawa N/A
Country [43] 0 0
Taiwan
State/province [43] 0 0
Kaohsiung County

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 evaluate the efficacy and safety of golimumab, alone or in
combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid
arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.
Trial website
https://clinicaltrials.gov/show/NCT00264550
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