Trial Outcomes & Findings for Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate (NCT NCT00083759)

NCT ID: NCT00083759

Last Updated: 2016-07-18

Results Overview

≥20% reduction from baseline in painful/tender joint count and swollen joint count and ≥20% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 299 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2016-07-18

Participant Flow

First patient entered 24 May 2004, study terminated 28 February 2005. A total of 299 patients were evaluable for safety and 273 patients for efficacy. Study conducted in Argentina, Australia, Canada, Czech Republic, Poland, Slovakia, and the United States.

Patients who met these criteria were randomized to natalizumab or placebo: aged 18-75 with a diagnosis of rheumatoid arthritis (RA) Functional Class 1-3 for ≥ 6 months, on a stable dose of methotrexate (MTX), having ≥ 10 painful/tender joints, and with elevated C-reactive protein. Stratification based on baseline number of painful/tender joints.

Participant milestones

Measure	Natalizumab Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)	Placebo Placebo IV infusions + methotrexate (MTX)
Overall Study STARTED	150	149
Overall Study COMPLETED	66	66
Overall Study NOT COMPLETED	84	83

Reasons for withdrawal

Measure	Natalizumab Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)	Placebo Placebo IV infusions + methotrexate (MTX)
Overall Study Adverse Event	5	3
Overall Study Lost to Follow-up	1	0
Overall Study Death	1	1
Overall Study Inadequate Therapeutic Response	32	35
Overall Study Subject Withdrew Consent	2	2
Overall Study Non-Compliance	1	0
Overall Study Sponsor's Discretion	28	29
Overall Study Other	14	13

Baseline Characteristics

Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

Baseline characteristics by cohort

Measure	Natalizumab n=137 Participants Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)	Placebo n=136 Participants Placebo IV infusions + methotrexate (MTX)	Total n=273 Participants Total of all reporting groups
Age, Continuous	50.9 years STANDARD_DEVIATION 10.5 • n=5 Participants	53.6 years STANDARD_DEVIATION 10.4 • n=7 Participants	52.3 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants	107 Participants n=7 Participants	218 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Baseline Count of Painful/Tender Joints <20	44 participants n=5 Participants	43 participants n=7 Participants	87 participants n=5 Participants
Baseline Count of Painful/Tender Joints >20	93 participants n=5 Participants	93 participants n=7 Participants	186 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

≥20% reduction from baseline in painful/tender joint count and swollen joint count and ≥20% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)

Outcome measures

Measure	Natalizumab n=137 Participants Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)	Placebo n=136 Participants Placebo IV infusions + methotrexate (MTX)
American College of Rheumatology (ACR)20.	59 participants	45 participants

SECONDARY outcome

Timeframe: Month 6

≥50% reduction from baseline in painful/tender joint count and swollen joint count and ≥50% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)

Outcome measures

Measure	Natalizumab n=137 Participants Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)	Placebo n=136 Participants Placebo IV infusions + methotrexate (MTX)
American College of Rheumatology (ACR)50	23 participants	15 participants

SECONDARY outcome

Timeframe: Month 6

≥70% reduction from baseline in painful/tender joint count and swollen joint count and ≥70% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)

Outcome measures

Measure	Natalizumab n=137 Participants Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)	Placebo n=136 Participants Placebo IV infusions + methotrexate (MTX)
American College of Rheumatology (ACR)70	13 participants	10 participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Biogen Study Medical Director

Biogen

Email: clinicaltrials@biogen.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor will have at least 30 days to request revisions to a proposed Publication. Institution will delete any Confidential Information provided by Sponsor, will delay Publication submission for a further 90 days for the filing of patent applications, and will not issue a press release about the Study without the Sponsor's prior written consent.
• Publication restrictions are in place

Restriction type: OTHER